TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES

Manufacturer: Rebel Distributors Corp.
Effective date: 2009-12-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:07:44

Label at a glance#

ProductTrimethobenzamide Hydrochloride

Active ingredientTrimethobenzamide Hydrochloride

Label structure12 sections

Indications and uses

Trimethobenzamide hydrochloride capsules are indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

Dosage and administration

(See WARNINGS and PRECAUTIONS .) Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient. Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤70 mL/min/1.73m 2 ). Final dose adjustment should be based upon int...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION

DESCRIPTION SECTION

Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the following structural formula:

Each capsule for oral use contains trimethobenzamide hydrochloride equivalent to 300 mg.

Inactive Ingredients: FDA/E172 Red Iron Oxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and titanium dioxide. The imprinting ink contains D&C Yellow #10 Lake, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, Iron Oxide Black, propylene glycol and shellac glaze.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Mechanism of Action

MECHANISM OF ACTION SECTION

The mechanism of action of trimethobenzamide hydrochloride capsules as determined in animals is obscure, but may involve the chemoreceptor trigger zone (CTZ), an area in the medulla oblongata through which emetic impulses are conveyed to the vomiting center; direct impulses to the vomiting center apparently are not similarly inhibited. In dogs pretreated with trimethobenzamide HCl, the emetic response to apomorphine is inhibited, while little or no protection is afforded against emesis induced by intragastric copper sulfate.

Pharmacokinetics

PHARMACOKINETICS SECTION

The pharmacokinetics of trimethobenzamide have been studied in healthy adult subjects. Following administration of 200 mg (100 mg/mL) trimethobenzamide hydrochloride I.M. injection, the time to reach maximum plasma concentration (T_max) was about half an hour, about 15 minutes longer for trimethobenzamide hydrochloride 300 mg oral capsule than an I.M. injection. A single dose of trimethobenzamide hydrochloride 300 mg oral capsule provided a plasma concentration profile of trimethobenzamide similar to trimethobenzamide hydrochloride 200 mg I.M. The relative bioavailability of the capsule formulation compared to the solution is 100%. The mean elimination half-life of trimethobenzamide is 7 to 9 hours. Between 30 – 50% of a single dose in humans is excreted unchanged in the urine within 48–72 hours. The major pathway of trimethobenzamide metabolism is through oxidation resulting in the formation of trimethobenzamide N-oxide metabolite. The pharmacologic activity of this major metabolite has not been evaluated.

Special Populations

SPL UNCLASSIFIED SECTION

Age

SPL UNCLASSIFIED SECTION

The clearance of trimethobenzamide is not known in patients with renal impairment. However, it may be advisable to consider reduction in the dosing of trimethobenzamide in elderly patients with renal impairment considering that a substantial amount of excretion and elimination of trimethobenzamide occurs via the kidney and that elderly patients may have various degrees of renal impairment. (See PRECAUTIONS: General and DOSAGE AND ADMINISTRATION).

Gender

SPL UNCLASSIFIED SECTION

Systemic exposure to trimethobenzamide was similar between men (N=40) and women (N=28).

Race

SPL UNCLASSIFIED SECTION

Pharmacokinetics appeared to be similar for Caucasians (N=53) and African Americans (N=12).

Renal Impairment

SPL UNCLASSIFIED SECTION

The clearance of trimethobenzamide is not known in patients with renal impairment. However, it may be advisable to consider reduction in the dosing of trimethobenzamide in patients with renal impairment considering that a substantial amount of excretion and elimination of trimethobenzamide occurs via the kidney. (See PRECAUTIONS: General and DOSAGE AND ADMINISTRATION).

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Trimethobenzamide hydrochloride capsules are indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Use of any dosage form in patients with known hypersensitivity to trimethobenzamide is contraindicated.

WARNINGS

WARNINGS SECTION

Caution should be exercised when administering trimethobenzamide hydrochloride capsules to children for the treatment of vomiting. Antiemetics are not recommended for treatment of uncomplicated vomiting in children and their use should be limited to prolonged vomiting of known etiology. There are two principal reasons for caution:

The extrapyramidal symptoms which can occur secondary to trimethobenzamide hydrochloride capsules may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye's syndrome or other encephalopathy.
It has been suspected that drugs with hepatotoxic potential, such as trimethobenzamide hydrochloride capsules, may unfavorably alter the course of Reye's syndrome. Such drugs should therefore be avoided in children whose signs and symptoms (vomiting) could represent Reye's syndrome.

Trimethobenzamide hydrochloride capsules may produce drowsiness. Patients should not operate motor vehicles or other dangerous machinery until their individual responses have been determined.

Usage in Pregnancy

PREGNANCY SECTION

Trimethobenzamide hydrochloride was studied in reproduction experiments in rats and rabbits and no teratogenicity was suggested. The only effects observed were an increased percentage of embryonic resorptions or stillborn pups in rats administered 20 mg and 100 mg/kg and increased resorptions in rabbits receiving 100 mg/kg. In each study these adverse effects were attributed to one or two dams. The relevance to humans is not known. Since there is no adequate experience in pregnant or lactating women who have received this drug, safety in pregnancy or in nursing mothers has not been established.

Usage with Alcohol

SPL UNCLASSIFIED SECTION

Concomitant use of alcohol with trimethobenzamide hydrochloride capsules may result in an adverse drug interaction.

PRECAUTIONS

PRECAUTIONS SECTION

During the course of acute febrile illness, encephalitides, gastroenteritis, dehydration and electrolyte imbalance, especially in children and the elderly or debilitated, CNS reactions such as opisthotonos, convulsions, coma and extrapyramidal symptoms have been reported with and without use of trimethobenzamide hydrochloride capsules or other antiemetic agents. In such disorders caution should be exercised in administering trimethobenzamide hydrochloride capsules, particularly to patients who have recently received other CNS-acting agents (phenothiazines, barbiturates, belladonna derivatives). Primary emphasis should be directed toward the restoration of body fluids and electrolyte balance, the relief of fever and relief of the causative disease process. Overhydration should be avoided since it may result in cerebral edema.

The antiemetic effects of trimethobenzamide hydrochloride capsules may render diagnosis more difficult in such conditions as appendicitis and obscure signs of toxicity due to overdosage of other drugs.

General

GENERAL PRECAUTIONS SECTION

Adjustment of Dose in Renal Failure

SPL UNCLASSIFIED SECTION

A substantial route of elimination of unchanged trimethobenzamide is via the kidney. Dosage adjustment should be considered in patients with reduced renal function including some elderly patients. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Geriatric Use

GERIATRIC USE SECTION

Clinical studies of trimethobenzamide hydrochloride did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Although there are studies reported in the literature that included elderly patients >65 years old with younger patients, it is not known if there are differences in efficacy or safety parameters for elderly and non-elderly patients treated with trimethobenzamide. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

There have been reports of hypersensitivity reactions and Parkinson-like symptoms. There have been instances of hypotension reported following parenteral administration to surgical patients. There have been reports of blood dyscrasias, blurring of vision, coma, convulsions, depression of mood, diarrhea, disorientation, dizziness, drowsiness, headache, jaundice, muscle cramps and opisthotonos. If these occur, the administration of the drug should be discontinued. Allergic-type skin reactions have been observed; therefore, the drug should be discontinued at the first sign of sensitization. While these symptoms will usually disappear spontaneously, symptomatic treatment may be indicated in some cases.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

(See WARNINGS and PRECAUTIONS.)

Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.

Geriatric Patients

SPL UNCLASSIFIED SECTION

Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤70 mL/min/1.73m²). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

Patients with Renal Impairment

SPL UNCLASSIFIED SECTION

In subjects with renal impairment (creatinine clearance ≤70 mL/min/1.73m²), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

CAPSULES, 300 mg

Usual Adult Dosage

SPL UNCLASSIFIED SECTION

One 300 mg capsule t.i.d. or q.i.d.

HOW SUPPLIED

HOW SUPPLIED SECTION

Trimethobenzamide hydrochloride capsules are supplied as follows:

Trimethobenzamide hydrochloride capsules 300 mg, swedish orange opaque, imprinted MUTUAL over 401 on both the body and cap.

Bottles of 10	NDC 21695-448-10

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

SPL UNCLASSIFIED SECTION

Manufactured by:
Mutual Pharmaceutical Company, Inc.
Philadelphia, PA 19124 USA

Repackaged by:
Rebel Distributors Corp.
Thousand Oaks, CA 91320

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
860771	trimethobenzamide HCl 300 MG Oral Capsule	PSN	1
860771	trimethobenzamide hydrochloride 300 MG Oral Capsule	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TRIMETHOBENZAMIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5cb11add-3f77-4e14-9823-b8ca5e31d965	Product name	1	20250804

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-448-10	2019-09-24	C162847	48780-1	934fe258-4a9d-48b1-e053-8cdaa90a720a	TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-448-10	Trimethobenzamide Hydrochloride	10 in 1 BOTTLE, PLASTIC	CAPSULE	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-448	TRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 1 package rows	20100105_43a47783-c605-49eb-a4fa-8524e75e69de.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-448-10	EA - Each	21695-448	fea6d77d-919a-44c0-af03-0ead3ab78453	1	2012-07-24
53489-376-01	EA - Each	53489-376	f9cf26a7-4143-4ff0-8e25-22e837a012fd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Trimethobenzamide Hydrochloride	ACTIVE INGREDIENT	WDQ5P1SX7Q	1
Trimethobenzamide	ACTIVE MOIETY	W2X096QY97	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
D&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
D&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Shellac	INACTIVE INGREDIENT	46N107B71O	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Trimethobenzamide Hydrochloride
Trimethobenzamide
gelatin
magnesium stearate
cellulose, microcrystalline
sodium starch glycolate type A potato
titanium dioxide
FD&C Blue No. 2
D&C Red No. 40
D&C Blue No. 1
D&C Yellow No. 10
ferrosoferric oxide
Shellac
propylene glycol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
21695-448	21695-448-10
53489-376

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Trimethobenzamide Hydrochloride	WDQ5P1SX7Q	ACTIM
gelatin	2G86QN327L	IACT
magnesium stearate	70097M6I30	IACT
cellulose, microcrystalline	OP1R32D61U	IACT
sodium starch glycolate type A potato	5856J3G2A2	IACT
titanium dioxide	15FIX9V2JP	IACT
FD&C Blue No. 2	L06K8R7DQK	IACT
D&C Red No. 40	WZB9127XOA	IACT
D&C Blue No. 1	H3R47K3TBD	IACT
D&C Yellow No. 10	35SW5USQ3G	IACT
ferrosoferric oxide	XM0M87F357	IACT
Shellac	46N107B71O	IACT
propylene glycol	6DC9Q167V3	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 362 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / SUBLINGUAL	0.23 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Shellac	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
ferrosoferric oxide	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, COATED / ORAL	0.11 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
D&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C Blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE / ORAL		4 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
Shellac	SHELLAC	46N107B71O	FILM / SUBLINGUAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
FD&C Blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, FILM COATED / ORAL		2 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
D&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii candidate 37 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
D&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C Blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, DELAYED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
D&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SUSPENSION / ORAL	1 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	LOTION / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Shellac	SHELLAC	46N107B71O	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C Blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL		25 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE / ORAL	20 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
D&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 28 equally ranked IID candidates
D&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION / INTRAMUSCULAR	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
D&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C Blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, CHEWABLE / ORAL		3 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
D&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	GEL / DENTAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076570-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076570-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076570-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076570-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076570-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076570-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076570-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076570-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076570-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076570-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076570-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076570-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076570-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076570-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076570-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076570-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076570-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076570-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076570-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076570-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076570-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076570-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076570-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076570-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076570-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076570-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076570-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076570-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076570-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076570-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c6a941a0-67dd-4c2a-accd-3a4578bc409c			43a47783-c605-49eb-a4fa-8524e75e69de	2009-12-01	Warnings, Adverse reactions	Exact identifier spl id: c6a941a0-67dd-4c2a-accd-3a4578bc409c spl set id: 43a47783-c605-49eb-a4fa-8524e75e69de

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.