MECLIZINE

Product NDC: 16103-386
11-digit product format: 161030386
Labeler code: 16103
Product ID: 16103-386_d7d81436-c338-4988-bf9e-a721e0cb8f91
Type: HUMAN OTC DRUG
Nonproprietary name: Meclizine HCl 12.5 mg
Dosage form: TABLET
Route: ORAL
Labeler: Pharbest Pharmaceuticals, Inc.
Application: M009
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-02-01
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 12.5 mg/1
Pharmacologic classes: Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-386-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-386-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-386-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-386-11	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-386-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-386-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-386-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-386-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-386-08	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-386-11	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-386-08	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-386-11	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16103-386-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16103-386-11	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16103-386-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16103-386-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16103-386-08	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16103-386-11	`bd6a592717d7…`	`303034d00443…`

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	12.5 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
995624	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
8b3c9283-b618-4d57-9f15-7cf73e8737f5	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
16103-386-08	2024-12-31	Drug Facts
16103-386-11	2024-12-31	Drug Facts
16103-386-08	2022-01-28	Drug Facts
16103-386-11	2022-01-28	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16103-386-08	MECLIZINE	100 in 1 BOTTLE, PLASTIC	TABLET	100		3
16103-386-11	MECLIZINE	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-386-08	EA - Each	16103-386	2154668d-662d-47cf-bbf1-5bb5c63c750d	1	2019-04-11
16103-386-11	EA - Each	16103-386	51f253cb-57da-41ee-bc3e-9f303e042a0e	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-386	MECLIZINE (MECLIZINE HCL 12.5 MG) TABLET [PHARBEST PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20250101_8b3c9283-b618-4d57-9f15-7cf73e8737f5.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 3 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	d0d8b376-8fe9-8776-e053-2a95a90ae651	2026-01-27	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4f806804-48c7-414e-a177-5d3daf5b22e3	2026-01-20	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	United Natural Foods, Inc. dba UNFI	108bb943-529f-4510-b770-b54eca493ae0	2026-01-12	Warnings	Exact identifier application number: M009
Less Drowsy Motion Sickness Relief	MECLIZINE HCL	Rite Aid Corporation	2f9ebe6b-ffde-41de-9eaa-b03d87d33005	2026-01-09	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE	Rite Aid Corporation	4f532984-aeee-4dde-972c-742bdf12868f	2026-01-07	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	Family Dollar Services Inc	e34126e3-52ef-4999-bf61-cba9b1818259	2026-01-05	Warnings	Exact identifier application number: M009
CVS Motion Sickness Fast Melting	MECLIZINE HYDROCHLORIDE	CVS Pharmacy, Inc.	2a723bce-a581-4558-b028-22f1f9125dd5	2025-12-30	Warnings	Exact identifier application number: M009
Wal-Dram 2 Quick-Dissolving	MECLIZINE HYDROCHLORIDE	Walgreen Co.	f3116203-1b8f-438a-b779-7bdd90eaf79e	2025-12-30	Warnings	Exact identifier application number: M009
MECLIZINE	MECLIZINE HCL 12.5 MG	Pharbest Pharmaceuticals, Inc.	8b3c9283-b618-4d57-9f15-7cf73e8737f5	2025-12-24	Warnings	Exact identifier application number: M009 ndc (product): 16103-386
MECLIZINE	MECLIZINE HCL 25MG	Pharbest Pharmaceuticals, Inc.	4bac2765-045c-405e-8006-8c5cfdfa89bc	2025-12-24	Warnings	Exact identifier application number: M009
DRAMAMINE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	fdcbcc4e-9370-4975-8905-1f12c73fdc8c	2025-12-23	Warnings	Exact identifier application number: M009
DRAMAMINE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	3a960d43-62aa-464e-92b9-d83042ba02bf	2025-12-23	Warnings	Exact identifier application number: M009
DRAMAMINE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	6efd3473-ee14-4ee0-8a58-d15a64a9224a	2025-12-18	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	Rite Aid Corporation	e599dc64-ac10-4f4e-9318-e9fab0526488	2025-11-15	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	Kroger Company	64e0496c-5e09-46e9-94b9-624163d71b60	2025-11-05	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	Walgreen Company	27bd9c74-c85e-4eeb-9e43-4120f9001187	2025-11-05	Warnings	Exact identifier application number: M009
Dramamine Original Formula	DIMENHYDRINATE	Medtech Products Inc.	f9302a5a-295a-4501-9332-e3f5eb387362	2025-10-23	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	CVS Pharmacy, Inc	b57fc6c2-fbfc-24c3-e053-2995a90a3389	2025-10-16	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	Amerisource Bergen	503f62e7-8ec8-4409-9697-4efef4ff7b15	2025-10-08	Warnings	Exact identifier application number: M009
Meclizine HCL 25 mg	MECLIZINE HCL	Proficient Rx LP	d08fa6f5-4293-4468-814e-7dccbd281209	2025-10-01	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
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	8b3c9283-b618-4d57-9f15-7cf73e8737f5	3
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	99b87792-f0b8-458f-9316-0d0c9e1d1684	3
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	8b3c9283-b618-4d57-9f15-7cf73e8737f5	3
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	99b87792-f0b8-458f-9316-0d0c9e1d1684	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16103-386-08	16103038608	100 TABLET in 1 BOTTLE, PLASTIC (16103-386-08)	100 tablet	2018-02-01	0000-00-00	No	No	Current
16103-386-11	16103038611	1000 TABLET in 1 BOTTLE, PLASTIC (16103-386-11)	1000 tablet	2018-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Pharbest Pharmaceuticals, Inc.	2025-12-24	HUMAN OTC DRUG LABEL	3
Drug Facts	A-S Medication Solutions	2020-05-12	HUMAN OTC DRUG LABEL	3