Meclizine HCl 25 mg

Product NDC: 51645-994
Requested package NDC: 51645-994-01
11-digit product format: 516450994
Labeler code: 51645
Product ID: 51645-994_b3dc2b97-9b7b-1ced-e053-2a95a90a403c
Type: HUMAN OTC DRUG
Nonproprietary name: Meclizine Hydrochloride
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Gemini Pharmaceuticals, Inc. dba Plus Pharma
Application: part336
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-10-15
Marketing end: 0000-00-00
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51645-994	51645-994-01	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51645-994-01	EA - Each	51645-994	094ec1d6-7d2f-47b2-bfba-42e4d43dd5be	1	2016-03-04
51645-994-10	EA - Each	51645-994	1e7b29ee-6984-4e20-aacf-83d5b646caee	1	2016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
SODIUM SULFATE	INACTIVE INGREDIENT	0YPR65R21J	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1
TRICALCIUM PHOSPHATE	INACTIVE INGREDIENT	K4C08XP666	MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA]	1

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	a0d519ec-8a3d-4486-8364-e8ed40bef5cb	7
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	a0d519ec-8a3d-4486-8364-e8ed40bef5cb	7
995632	meclizine HCl 25 MG Chewable Tablet	PSN	505f6036-d216-4455-e054-00144ff88e88	4
995632	meclizine HCl 25 MG Chewable Tablet	PSN	ff14ae8b-bc67-4f79-958a-c2d968bfcc30	4
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	505f6036-d216-4455-e054-00144ff88e88	4
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	ff14ae8b-bc67-4f79-958a-c2d968bfcc30	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51645-994-01	51645099401	100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (51645-994-01)	2015-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meclizine HCl 25 mg Chewable Tablets	Bryant Ranch Prepack	2022-02-09	HUMAN OTC DRUG LABEL	7
Meclizine HCl 25 mg Chewable Tablets	Unit Dose Services	2021-09-22	HUMAN OTC DRUG LABEL	4
Meclizine HCl 25 mg Chewable Tablets	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-08-03	HUMAN OTC DRUG LABEL	2
Meclizine HCl 25 mg Chewable Tablets	NuCare Pharmceuticals,Inc. \| NuCare Pharmaceuticals,Inc.	2021-02-23	HUMAN OTC DRUG LABEL	5
Meclizine HCl 25 mg Chewable Tablets	Preferred Pharmaceuticals Inc.	2021-01-26	HUMAN OTC DRUG LABEL	1
Meclizine HCl 25 mg Chewable Tablets	RPK Pharmaceuticals, Inc.	2020-12-16	HUMAN OTC DRUG LABEL	3
Meclizine HCl 25 mg Chewable Tablets	Gemini Pharmaceuticals, Inc. dba Plus Pharma \| Gemini Pharmaceuticals, Inc.	2020-11-11	HUMAN OTC DRUG LABEL	3
Meclizine HCl 25 mg - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2020-01-20	HUMAN OTC DRUG LABEL	4
Meclizine HCl 25 mg Chewable Tablets	Proficient Rx LP	2019-11-01	HUMAN OTC DRUG LABEL	3
Meclizine HCl 25 mg Chewable Tablets	Pharmpak, Inc.	2019-08-20	HUMAN OTC DRUG LABEL	1
Meclizine HCl 25 mg Chewable Tablets	NuCare Pharmaceuticals, Inc.	2017-03-21	HUMAN OTC DRUG LABEL	1