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…`

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 1 of 6 · 117 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Motion Sickness Relief	DIMENHYDRINATE	Cardinal Health 110, LLC. DBA Leader	ce83a868-bdd8-4c77-9bc0-664133028f75	2026-08-06	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	L.N.K. International, Inc.	8e1889de-fbef-44f1-bbfb-c68a78e6330c	2026-07-30	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE	Chain Drug Marketing Association, Inc.	00a327c6-6b86-4702-8c04-55c405c1404c	2026-07-23	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Rugby Laboratories	b57f14a7-3852-03db-e053-2a95a90a80d6	2026-07-16	Warnings	Exact identifier application number: M009
Motion Sickness	DIMENHYDRINATE	CVS Pharmacy	0998947c-cfba-497e-bf7a-9c7f8fff1764	2026-07-16	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	Topco Associates, LLC	307e3144-3b01-4bd0-9155-6b58fc4cab92	2026-07-09	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE	L.N.K. International, Inc.	95aae32f-6b3f-469d-86a5-c201a53f862a	2026-06-29	Warnings	Exact identifier application number: M009
DRAMAMINE CHEWABLE ORANGE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	30387e63-278d-412a-bcad-7965c7c0aea7	2026-06-23	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE	Wal-Mart Stores Inc	c25a7f2b-0f01-4ec0-8849-f08c23608d1d	2026-06-22	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	Cardinal Health 110, LLC. DBA Leader	69099658-a584-49a9-8a95-de258a697c4f	2026-06-16	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE	Topco Associates, LLC	503a70db-d564-4ea0-851e-8ff617e70728	2026-06-16	Warnings	Exact identifier application number: M009
Motion Sickness	MECLIZINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	20229ad5-cb28-4667-ab70-97a1102873a2	2026-06-16	Warnings	Exact identifier application number: M009
Motion Sickness	DIMENHYDRINATE	Geiss, Destin & Dunn Inc.	fdb683c5-ff7f-4b93-9892-670cf1f29f2a	2026-06-15	Warnings	Exact identifier application number: M009
Dimenhydrinate	DIMENHYDRINATE	CVS Pharmacy, Inc.	6dfc5cb4-af0c-56c9-e053-2a91aa0a5d56	2026-06-12	Warnings	Exact identifier application number: M009
Driminate	DIMENHYDRINATE	Major Pharmaceuticals	d2967f78-41ee-4c30-8b47-0757df9f3d91	2026-06-10	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE	Amerisource Bergen	c4077301-db6c-473d-beb3-232d7134a13a	2026-06-03	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	Walgreen Company	761b7f9d-eaa1-47f0-89d9-c2da0e364a8b	2026-05-18	Warnings	Exact identifier application number: M009
Motion Sickness	MECLIZINE HCL	Strategic Sourcing Services LLC	550b803c-a038-455c-908a-a6244c0952ba	2026-05-12	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE	Valu Merchandisers Company	56c26102-8d39-458e-b076-3fe67456a4c0	2026-04-16	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	DOLGENCORP, LLC	1616c540-dcd9-46f1-823f-27b67ef488d2	2026-04-16	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