Meclizine HCL 25 mg

Product NDC: 69618-028
11-digit product format: 696180028
Labeler code: 69618
Product ID: 69618-028_2bc84375-4d37-4be4-e063-6394a90a63f6
Type: HUMAN OTC DRUG
Nonproprietary name: Meclizine HCL
Dosage form: TABLET
Route: ORAL
Labeler: Reliable 1 Laboratories LLC
Application: M009
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-11-01
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 HCL 25 mg
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
32bdd802-16b0-184d-e054-00144ff88e88	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69618-028-01	2023-03-29	Meclizine HCL 25 mg
69618-028-10	2023-03-29	Meclizine HCL 25 mg
69618-028-01	2023-01-30	Meclizine HCL 25 mg
69618-028-10	2023-01-30	Meclizine HCL 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69618-028-01	Meclizine HCL 25 mg	100 in 1 BOTTLE, PLASTIC	TABLET	100		6
69618-028-10	Meclizine HCL 25 mg	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69618-028-01	EA - Each	69618-028	05854f16-ef26-4281-a82d-55afaf652f52	1	2016-05-16
69618-028-10	EA - Each	69618-028	34099ed8-cfa9-415b-92f0-ce00963c6a36	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69618-028	MECLIZINE HCL 25 MG (MECLIZINE HCL) TABLET [RELIABLE 1 LABORATORIES LLC]	6	Current NDC, Legacy NDC, 2 package rows	20250117_32bdd802-16b0-184d-e054-00144ff88e88.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 · 112 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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	32bdd802-16b0-184d-e054-00144ff88e88	6
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	32bdd802-16b0-184d-e054-00144ff88e88	6
995632	meclizine HCl 25 MG Chewable Tablet	PSN	d1c58a74-5455-4a07-bcb6-cc114032ed12	5
995632	meclizine HCl 25 MG Chewable Tablet	PSN	e4201bdc-18b4-4229-a7c0-300c5d5ad8db	5
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	d1c58a74-5455-4a07-bcb6-cc114032ed12	5
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	e4201bdc-18b4-4229-a7c0-300c5d5ad8db	5
995632	meclizine HCl 25 MG Chewable Tablet	PSN	d08fa6f5-4293-4468-814e-7dccbd281209	4
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	d08fa6f5-4293-4468-814e-7dccbd281209	4
995632	meclizine HCl 25 MG Chewable Tablet	PSN	a58d13fe-2920-3b43-e053-2a95a90a5b94	1
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	a58d13fe-2920-3b43-e053-2a95a90a5b94	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69618-028-01	69618002801	100 TABLET in 1 BOTTLE, PLASTIC (69618-028-01)	100 tablet	2015-11-01	0000-00-00	No	No	Current
69618-028-10	69618002810	1000 TABLET in 1 BOTTLE, PLASTIC (69618-028-10)	1000 tablet	2015-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meclizine HCL 25 mg	Preferred Pharmaceuticals Inc.	2026-06-12	HUMAN OTC DRUG LABEL	7
Meclizine HCL 25 mg	Proficient Rx LP	2025-10-01	HUMAN OTC DRUG LABEL	4
Meclizine HCL 25 mg	Bryant Ranch Prepack	2025-03-31	HUMAN OTC DRUG LABEL	5
Meclizine HCL 25 mg	Reliable 1 Laboratories LLC	2025-01-15	HUMAN OTC DRUG LABEL	6
Meclizine HCL 25 mg	REMEDYREPACK INC.	2021-08-27	HUMAN OTC DRUG LABEL	1
Meclizine HCL 25 mg	Quality Care Products, LLC	2021-04-15	HUMAN OTC DRUG LABEL	3
Meclizine HCL 25 mg	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-18	HUMAN OTC DRUG LABEL	2
Meclizine HCL 25 mg	RedPharm Drug, Inc. \| EPM Packaging	2020-01-01	HUMAN OTC DRUG LABEL	1