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 5 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Motion Sickness Relief	DIMENHYDRINATE 50 MG	TARGET CORPORATION	28586e9b-01e3-0b88-e063-6394a90af7e0	2025-01-29	Warnings	Exact identifier application number: M009
MECLIZINE	MECLIZINE HCL 12.5MG	Ulai Health LLC	d304e205-85fa-494a-9a68-ae6855b139b1	2025-01-20	Warnings	Exact identifier application number: M009
Meclizine HCL 12.5 mg	MECLIZINE HCL 12.5 MG	Reliable 1 Laboratories LLC	32832b0f-0b38-27ce-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M009
Meclizine HCL 25 mg	MECLIZINE HCL	Reliable 1 Laboratories LLC	32bdd802-16b0-184d-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	e4d785a7-a688-3acb-e053-2a95a90a6d2e	2025-01-09	Boxed warning, Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	ed43bf21-f3da-245c-e053-2995a90a504c	2025-01-09	Boxed warning, Warnings	Exact identifier application number: M009
MECLIZINE	MECLIZINE HCL 12.5 MG	RUGBY LABORATORIES	8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35	2024-12-20	Warnings	Exact identifier application number: M009
Meclizine	MECLIZINE HYDROCHLORIDE	Advanced Rx LLC	b0a2a1f7-354e-48bd-9e98-9207bf9f53fd	2024-11-27	Warnings	Exact identifier application number: M009
Dramamine, TRAVEL BASIX	DIMENHYDRINATE	Lil' Drug Store Products, Inc.	960a642b-ee7c-4e92-9b5f-930425682dac	2024-11-26	Warnings	Exact identifier application number: M009
Dramamine Less Drowsy, Lil Drug Store	MECLAZINE HYDROCHLORIDE TABLET	Lil' Drug Store Products, Inc.	275b3377-9280-c12c-e063-6294a90a5421	2024-11-20	Warnings	Exact identifier application number: M009
PhysiciansCare Motion Sickness	MECLIZINE HCL	Acme United Corporation	c4d3ea22-7c22-7311-e053-2a95a90a779c	2024-11-12	Warnings	Exact identifier application number: M009
DRAMAMINE - N	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	7fec7791-c242-4e43-8184-32820e657afb	2024-10-25	Warnings	Exact identifier application number: M009
DRAMAMINE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	f8cf751a-9f19-4744-a350-cd22303435ee	2024-10-25	Warnings	Exact identifier application number: M009
Gravol	DIMENHYDRINATE	Church & Dwight Co., Inc.	d955f612-1265-f1be-e053-2995a90a5345	2024-07-18	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	199ae195-4556-ee88-e063-6394a90a40d4	2024-06-10	Warnings	Exact identifier application number: M009
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

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