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 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
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