Meclizine Hydrochloride

Product NDC: 72789-250
11-digit product format: 727890250
Labeler code: 72789
Product ID: 72789-250_5b7520ea-1e34-7c09-e063-6394a90a9c59
Type: HUMAN OTC DRUG
Nonproprietary name: Meclizine Hydrochloride
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: M009
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-10-30
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MECLIZINE HYDROCHLORIDE	25 mg/1

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	SPL version
72789-250-12	Meclizine Hydrochloride	12 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	12	6
72789-250-20	Meclizine Hydrochloride	20 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	20	6
72789-250-30	Meclizine Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-250-12	EA - Each	72789-250	99714d98-f55e-4133-b044-1a354ce6b946	1	2022-06-06
72789-250-20	EA - Each	72789-250	bd855766-f5cd-4460-82b0-e3eb4247ca04	1	2022-06-06
72789-250-30	EA - Each	72789-250	72674653-d51d-467d-a90b-cb57cd7b731c	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-250	MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 3 package rows	20240426_a9ad5d27-306d-48ca-a10d-0a0415d08f05.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	a9ad5d27-306d-48ca-a10d-0a0415d08f05	6
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	a9ad5d27-306d-48ca-a10d-0a0415d08f05	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-250-12	72789025012	12 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (72789-250-12)	2022-05-05	0000-00-00	No	No	Current
72789-250-20	72789025020	20 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (72789-250-20)	2022-05-05	0000-00-00	No	No	Current
72789-250-30	72789025030	30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (72789-250-30)	2022-05-05	0000-00-00	No	No	Current