MECLIZINE

Product NDC: 43063-804
11-digit product format: 430630804
Labeler code: 43063
Product ID: 43063-804_2fb4b0a4-ecff-437f-e063-6394a90a2d5f
Type: HUMAN OTC DRUG
Nonproprietary name: Meclizine HCl 25mg
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: M009
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-02-01
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 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	25 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
995632	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
cf79ac74-017e-4fb4-85d3-4ea944080e89	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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43063-804-01	MECLIZINE	100 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	100	14
43063-804-06	MECLIZINE	6 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	6	14
43063-804-12	MECLIZINE	12 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	12	14
43063-804-20	MECLIZINE	20 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	20	14
43063-804-30	MECLIZINE	30 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	30	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-804-01	EA - Each	43063-804	f0e47f6b-3f09-43d8-8ce2-771a1846c268	1	2018-03-08
43063-804-12	EA - Each	43063-804	939a1d6b-47bf-4263-a894-09879823b0a3	1	2018-01-12
43063-804-20	EA - Each	43063-804	5504be70-097b-4721-ba3c-f1d227ff8cb6	1	2018-02-20
43063-804-30	EA - Each	43063-804	16228db3-bdfd-44a7-886f-1f0caf69e7b7	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-804	MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	14	Current NDC, Legacy NDC, 5 package rows	20250313_cf79ac74-017e-4fb4-85d3-4ea944080e89.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 5 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Motion Sickness Relief	DIMENHYDRINATE 50 MG	TARGET CORPORATION	28586e9b-01e3-0b88-e063-6394a90af7e0	2025-01-29	Warnings	Exact identifier application number: M009
MECLIZINE	MECLIZINE HCL 12.5MG	Ulai Health LLC	d304e205-85fa-494a-9a68-ae6855b139b1	2025-01-20	Warnings	Exact identifier application number: M009
Meclizine HCL 12.5 mg	MECLIZINE HCL 12.5 MG	Reliable 1 Laboratories LLC	32832b0f-0b38-27ce-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M009
Meclizine HCL 25 mg	MECLIZINE HCL	Reliable 1 Laboratories LLC	32bdd802-16b0-184d-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	e4d785a7-a688-3acb-e053-2a95a90a6d2e	2025-01-09	Boxed warning, Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	ed43bf21-f3da-245c-e053-2995a90a504c	2025-01-09	Boxed warning, Warnings	Exact identifier application number: M009
MECLIZINE	MECLIZINE HCL 12.5 MG	RUGBY LABORATORIES	8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35	2024-12-20	Warnings	Exact identifier application number: M009
Meclizine	MECLIZINE HYDROCHLORIDE	Advanced Rx LLC	b0a2a1f7-354e-48bd-9e98-9207bf9f53fd	2024-11-27	Warnings	Exact identifier application number: M009
Dramamine, TRAVEL BASIX	DIMENHYDRINATE	Lil' Drug Store Products, Inc.	960a642b-ee7c-4e92-9b5f-930425682dac	2024-11-26	Warnings	Exact identifier application number: M009
Dramamine Less Drowsy, Lil Drug Store	MECLAZINE HYDROCHLORIDE TABLET	Lil' Drug Store Products, Inc.	275b3377-9280-c12c-e063-6294a90a5421	2024-11-20	Warnings	Exact identifier application number: M009
PhysiciansCare Motion Sickness	MECLIZINE HCL	Acme United Corporation	c4d3ea22-7c22-7311-e053-2a95a90a779c	2024-11-12	Warnings	Exact identifier application number: M009
DRAMAMINE - N	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	7fec7791-c242-4e43-8184-32820e657afb	2024-10-25	Warnings	Exact identifier application number: M009
DRAMAMINE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	f8cf751a-9f19-4744-a350-cd22303435ee	2024-10-25	Warnings	Exact identifier application number: M009
Gravol	DIMENHYDRINATE	Church & Dwight Co., Inc.	d955f612-1265-f1be-e053-2995a90a5345	2024-07-18	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	199ae195-4556-ee88-e063-6394a90a40d4	2024-06-10	Warnings	Exact identifier application number: M009
Gravol	DIMENHYDRINATE	Church & Dwight Co., Inc.	d941705f-12a1-4757-e053-2995a90ad3fa	2024-05-13	Warnings	Exact identifier application number: M009
Kids Gravol Chewables Motion Sickness Dimenhydrinate	DIMENHYDRINATE	Church & Dwight Co., Inc.	cf6de950-a157-4be2-a302-0dc19511d2f2	2024-03-01	Warnings	Exact identifier application number: M009
Gravol Chewables Motion Sickness Dimenhydrinate	DIMENHYDRINATE	Church & Dwight Co., Inc.	de5249f7-79fc-4f3c-965a-1e8ec978a0b7	2024-03-01	Warnings	Exact identifier application number: M009
Meclizine HCl	MECLIZINE HYDROCHLORIDE CHEWABLE	BluePoint Laboratories	d9cc2705-9dcc-0a73-e053-2995a90aafe6	2024-02-21	Warnings	Exact identifier application number: M009
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	DeMoulas Market Basket	fd04fb94-f581-4ca2-b7ac-20359093863e	2023-12-29	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
995632	meclizine HCl 25 MG Chewable Tablet	PSN	cf79ac74-017e-4fb4-85d3-4ea944080e89	14
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	cf79ac74-017e-4fb4-85d3-4ea944080e89	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-804-01	43063080401	100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-01)	2018-02-18	2027-11-30	No	No	Current
43063-804-06	43063080406	6 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-06)	2018-07-23	2027-11-30	No	No	Current
43063-804-12	43063080412	12 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-12)	2018-02-01	2027-11-30	No	No	Current
43063-804-20	43063080420	20 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-20)	2018-02-01	2027-11-30	No	No	Current
43063-804-30	43063080430	30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-30)	2018-02-01	2027-11-30	No	No	Current