BENZONATATE 100MG CAPSULE

Manufacturer: Life Line Home Care Services, Inc.
Effective date: 2012-01-12
Label type: Human Prescription Drug Label
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:14:00

Label at a glance#

ProductBENZONATATE

Active ingredientBENZONATATE

Label structure11 sections

Indications and uses

Benzonatate capsules are indicated for the symptomatic relief of cough.

Dosage and administration

Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

Label contents#

Full prescribing information#

DESCRIPTION

Description section

Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan- 28-yl p-(butylamino) benzoate. The molecular formula is C₃₀H₅₃NO₁₁ with a molecular weight of 603.7.

Each capsule, for oral administration, contains 100 mg or 200 mg of benzonatate, USP.

Benzonatate Capsules also contain: Alcohol, ammonium hydroxide, D&C Yellow 10, gelatin, glycerin, propylene glycol, purified water, shellac glaze, simethicone and titanium dioxide. In addition, the capsule may contain trace amounts of fractionated coconut oil.

CLINICAL PHARMACOLOGY

Clinical Pharmacology section

Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate capsules have no inhibitory effect on the respiratory center in recommended dosage.

INDICATIONS AND USAGE

Indications & Usage section

Benzonatate capsules are indicated for the symptomatic relief of cough.

CONTRAINDICATIONS

Contraindications section

Hypersensitivity to benzonatate or related compounds.

WARNINGS

Warnings section

Hypersensitivity

Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.

Psychiatric Effects

Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate capsules in combination with other prescribed drugs.

Accidental Ingestion and Death in Children

Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE).

PRECAUTIONS

Precautions section

Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.

Information for Patients:

Information for Patients section

Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut or crush benzonatate capsules. Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.

Keep benzonatate capsules out of reach of children. Accidental ingestion resulting in death has been reported in children.Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.

Overdosage resulting in death may occur in adults.

Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate capsules, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate capsules at one time.

Usage in Pregnancy:

Pregnancy section

Pregnancy Category C. Animal reproduction studies have not been conducted with benzonatate. It is also not known whether benzonatate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate capsules should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

Nursing Mothers section

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when benzonatate capsules are administered to a nursing woman.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Carcinogenesis & Mutagenesis & Impairment of Fertility section

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate.

Pediatric Use:

Pediatric Use section

Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

ADVERSE REACTIONS

Adverse Reactions section

Potential Adverse Reactions to benzonatate capsules may include:

Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.

GI: constipation; nausea; GI upset.

Dermatologic: pruritus; skin eruptions.

Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity.

Deliberate or accidental overdose has resulted in death, particularly in children.

OVERDOSAGE

Overdosage section

Intentional and unintentional overdose may result in death, particularly in children.

The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.

Signs and Symptoms:

SPL UNCLASSIFIED SECTION

The signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise.

CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion.

Treatment:

SPL UNCLASSIFIED SECTION

In case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copius amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage.

Do not use CNS stimulants.

DOSAGE AND ADMINISTRATION

Dosage & Administration section

Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

HOW SUPPLIED

How Supplied section

Benzonatate capsules, USP 100 mg are clear, yellow liquid filled in oval-shaped softgel capsule, imprinted “133” in white ink. The capsules are available as:

NDC 57664-133-88 Bottles of 100 CRC

NDC 57664-133-13 Bottles of 500

Benzonatate capsules, USP 200 mg are clear, yellow liquid filled in oval-shaped softgel capsule, imprinted “134” in white ink. The capsules are available as:

NDC 57664-134-88 Bottles of 100 CRC

NDC 57664-134-13 Bottles of 500

Store at 20° - 25°C (68° - 77°F). (See USP Controlled Room Temperature).

PROTECT FROM LIGHT.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP TIGHTLY CLOSED.

Distributed by:
Caraco Pharmaceutical Laboratories, Ltd.
Detroit, MI 48202
Affiliate of
Sun Pharmaceutical Industries, Inc.

6351T02
Rev. 3/2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 100 mg 30 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BENZONATATE (Benzonatate) Capsule

100MG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197397	benzonatate 100 MG Oral Capsule	PSN	1
197397	benzonatate 100 MG Oral Capsule	SCD	1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
dc429dc2-e942-6686-8d72-b63c57e806aa	Product name	5	20190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9	Product name	3	20190215
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75921-133-30	2019-11-13	C162847	48780-1	97449f38-d39a-f6ea-e053-dbdaa90aa703	BENZONATATE 100MG CAPSULE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75921-133-30	BENZONATATE	30 in 1 BOTTLE	CAPSULE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75921-133	BENZONATATE CAPSULE [LIFE LINE HOME CARE SERVICES, INC.]	1	Legacy NDC, 1 package rows	20120201_05b19502-15cb-4272-8efe-6b37b1863e63.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-133-88	EA - Each	57664-133	5636f477-7bc1-4b60-9f0d-70b7ecc30c2b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	1
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

BENZONATATE
ALCOHOL
AMMONIA
D&C YELLOW NO. 10
GELATIN
GLYCERIN
PROPYLENE GLYCOL
WATER
SHELLAC
DIMETHICONE
TITANIUM DIOXIDE
MEDIUM-CHAIN TRIGLYCERIDES

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
75921-133	75921-133-30
57664-133

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZONATATE	5P4DHS6ENR	ACTIB
ALCOHOL	3K9958V90M	IACT
AMMONIA	5138Q19F1X	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SHELLAC	46N107B71O	IACT
DIMETHICONE	92RU3N3Y1O	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	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 · 375 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	INJECTION, EMULSION / INTRAVENOUS	1.1 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 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
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CAPSULE / ORAL		4771 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, DELAYED RELEASE / ORAL	1.9 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	LOTION / TOPICAL	7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 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
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / PERIODONTAL	3.44 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER, FOR SUSPENSION / ORAL	3390 mg/5ml		Exact identifier — unii candidate 18 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE / ORAL	0.01 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 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
GELATIN	GELATIN	2G86QN327L	INJECTION / SUBCUTANEOUS	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	GUM, CHEWING / ORAL		2 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040587-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL			2008-03-19
A040587-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL			2008-03-19

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A040587-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040587-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040587-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040587-002	AA	1	`ea99ee380514…`

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
c9134869-a1de-44e6-9843-f9d1c576846c			05b19502-15cb-4272-8efe-6b37b1863e63	2012-01-12	Warnings, Adverse reactions	Exact identifier spl id: c9134869-a1de-44e6-9843-f9d1c576846c spl set id: 05b19502-15cb-4272-8efe-6b37b1863e63

Reported adverse events (FAERS/openFDA)#

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