MECLIZINE

Product NDC: 0536-1297
11-digit product format: 005361297
Labeler code: 0536
Product ID: 0536-1297_e35b2d6b-c702-4a55-a4bb-929b8a40012f
Type: HUMAN OTC DRUG
Nonproprietary name: Meclizine HCl 12.5 mg
Dosage form: TABLET
Route: ORAL
Labeler: RUGBY LABORATORIES
Application: M009
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-05-21
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 12.5 mg/1
Pharmacologic classes: Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: MECLIZINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MECLIZINE HYDROCHLORIDE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HDP7W44CIO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995624	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0536-1297-01	MECLIZINE	100 in 1 BOTTLE, PLASTIC	TABLET	100		4
0536-1297-10	MECLIZINE	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1297-10	EA - Each	0536-1297	b75e79a5-13b3-4cee-92ac-f0d9e67247ad	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-1297	MECLIZINE (MECLIZINE HCL 12.5 MG) TABLET [RUGBY LABORATORIES]	4	Current NDC, Legacy NDC, 2 package rows	20241222_8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35.zip

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 6 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Airmit Ace	DIMENHYDRINATE	Sato Pharmaceutical Co., Ltd.	a98d252d-4cfa-496a-ab2c-627f45f0d7d9	2023-12-01	Warnings	Exact identifier application number: M009
Meclizine HCl	MECLIZINE HYDROCHLORIDE	BluePoint Laboratories	d9cae5a6-8d4b-bdaf-e053-2995a90a7d44	2023-11-17	Warnings	Exact identifier application number: M009
ZenTrip Motion Sickness	MECLIZINE HYDROCHLORIDE	Sato Pharmaceutical Co., LTD	bd86c4c7-b6f0-e3e8-e053-2995a90a4454	2023-11-03	Warnings	Exact identifier application number: M009
Travel-Ease	MECLIZINE HCL	Geri-Care Pharmaceutical Corp	e3c64eb9-4972-29d9-e053-2a95a90a2a8a	2023-10-25	Warnings	Exact identifier application number: M009
Gravol	DIMENHYDRINATE	Church & Dwight Co., Inc.	d95240bb-02f2-3226-e053-2995a90afacd	2022-03-03	Warnings	Exact identifier application number: M009
Allergy DyeFree	ALLERGY DYEFREE	Allegiant Health	15736bb8-5a5b-489d-83ad-4cf34ec62956	2021-04-26	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE 50MG	Allegiant Health	7b0aa993-f08f-4dff-a82d-f35b3ebe3cc1	2019-12-12	Warnings	Exact identifier application number: M009

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HDP7W44CIO	MECLIZINE HYDROCHLORIDE	31884-77-2	MECLIZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35	4
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-1297-01	00536129701	100 TABLET in 1 BOTTLE, PLASTIC (0536-1297-01)	100 tablet	2020-05-21	0000-00-00	No	No	Current
0536-1297-10	00536129710	1000 TABLET in 1 BOTTLE, PLASTIC (0536-1297-10)	1000 tablet	2020-05-21	0000-00-00	No	No	Current