Meclizine Hydrochloride

Manufacturer: State of Florida DOH Central Pharmacy
Effective date: 2010-05-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:08:44

Label at a glance#

ProductMeclizine Hydrochloride

Active ingredientMECLIZINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

Dosage and administration

Motion Sickness: The initial dose of 25 to 50 mg meclizine hydrochloride, should be taken one hour prior to travel for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Meclizine hydrochloride, an oral antiemetic, is a white, slightly yellowish, crystalline powder which has a slight odor and is tasteless. It has the following structural formula:

C₂₅H₂₇CIN₂•2HCI•H₂O

M.W. 481.89

The chemical name is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) - piperazine dihydrochloride monohydrate.

Meclizine Hydrochloride Tablets are available in 12.5 mg, and *25 mg strengths for oral administration.

*Contains FD&C Yellow #5 (see PRECAUTIONS).

Each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, stearic acid and other ingredients. In addition, the 12.5 mg tablet contains FD&C Blue #1; and the 25 mg tablet contains D&C Yellow #10 and FD&C Yellow #5.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Meclizine hydrochloride is an antihistamine which shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

WARNINGS

WARNINGS SECTION

Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.

Patients should avoid alcoholic beverages while taking the drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland. Do not give to children under 12 years of age unless directed by a doctor.

PRECAUTIONS

PRECAUTIONS SECTION

The Meclizine Hydrochloride Tablets, 25 mg contain FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow #5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Usage in Children: Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended under 12 years of age.

Usage in Pregnancy:Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine hydrochloride increases the risk of abnormalities when administered during pregnancy.

Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine hydrochloride, or any other medication should be used during pregnancy only if clearly necessary.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Drowsiness, dry mouth, and on rare occasions, blurred vision have been reported.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Motion Sickness: The initial dose of 25 to 50 mg meclizine hydrochloride, should be taken one hour prior to travel for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

HOW SUPPLIED

HOW SUPPLIED SECTION

Meclizine Hydrochloride Tablets, USP 12.5 mg - blue, oval tablets debossed with “034” on one side and “par” on the other side. Tablets may contain characteristic dye spots.

Meclizine Hydrochloride Tablets, USP 25 mg - yellow, oval tablets debossed with “035” on one side and “par” on the other side.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC	Strength	Quantity/Form	Color	Source Prod. Code
53808-0380-1	25 mg	30 Tablets in a Blister Pack	YELLOW	49884-035

Dispense in tight, light-resistant containers as defined in the USP.

Store at controlled room temperature 15°-30°C (59°-86°F).

Manufactured by:

PAR PHARMACEUTICAL COMPANIES, INC.

Spring Valley, NY 10977

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

25mg Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
995666	meclizine HCl 25 MG Oral Tablet	PSN	1
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0380-1	2019-10-21	C162847	48780-1	956f9ecf-d821-621f-e053-dbdaa90a74ad	e6aa2220-2ef7-41d0-870d-e898ebcb4e7f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0380-1	Meclizine Hydrochloride	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0380	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100611_e6aa2220-2ef7-41d0-870d-e898ebcb4e7f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-035-01	EA - Each	49884-035	62a46d2b-5850-4125-8cee-02f2b08dc0d4	1	2012-07-24
49884-035-10	EA - Each	49884-035	c0c448f0-88c7-4282-9ec7-91ae0a7af6e3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	1
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Meclizine Hydrochloride
MECLIZINE
SILICON DIOXIDE
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID
FD&C YELLOW NO. 5
D&C YELLOW NO. 10

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53808-0380	53808-0380-1
49884-035

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MECLIZINE HYDROCHLORIDE	HDP7W44CIO	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
LACTOSE	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
STEARIC ACID	4ELV7Z65AP	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
D&C YELLOW NO. 10	35SW5USQ3G	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 5 · 253 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, EXTENDED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CONCENTRATE / ORAL	0.03 mg/1ml		Exact identifier — unii candidate 31 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
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / SUBLINGUAL	0.11 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LIQUID / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 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
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	ELIXIR / ORAL	0.3 mg/15ml		Exact identifier — unii candidate 31 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAVENOUS	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SYRUP / ORAL	0.1 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / ORAL		8 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A087128-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982
A087128-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A087128-001	AA
A087128-002	AA

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 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A087128-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087128-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A087128-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A087128-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087128-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A087128-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087128-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087128-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087128-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087128-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087128-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087128-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087128-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087128-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087128-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087128-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087128-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087128-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087128-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087128-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087128-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087128-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087128-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087128-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087128-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087128-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087128-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087128-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087128-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087128-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087128-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087128-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087128-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087128-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087128-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087128-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087128-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A087128-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087128-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A087128-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087128-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087128-001	AA	1	`bb7c543d1eb4…`

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
00973f5a-1447-4002-a86a-e2b61fad3678			e6aa2220-2ef7-41d0-870d-e898ebcb4e7f	2010-05-26	Warnings, Adverse reactions	Exact identifier spl id: 00973f5a-1447-4002-a86a-e2b61fad3678 spl set id: e6aa2220-2ef7-41d0-870d-e898ebcb4e7f

Reported adverse events (FAERS/openFDA)#

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