Bonine

Product NDC: 63736-124
11-digit product format: 637360124
Labeler code: 63736
Product ID: 63736-124_82885c3d-4964-44dd-8bb6-fe55afab3ce7
Type: HUMAN OTC DRUG
Nonproprietary name: meclizine hydrochloride
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Insight Pharmaceuticals
Application: part336
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2009-06-08
Marketing end: 0000-00-00
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63736-124		I	Inactivated by FDA	2026-08-11
excluded package	package	63736-124	63736-124-08	I	Inactivated by FDA	2026-08-11
excluded package	package	63736-124	63736-124-12	I	Inactivated by FDA	2026-08-11
excluded package	package	63736-124	63736-124-16	I	Inactivated by FDA	2026-08-11
excluded package	package	63736-124	63736-124-21	I	Inactivated by FDA	2026-08-11
excluded package	package	63736-124	63736-124-95	I	Inactivated by FDA	2026-08-11

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 3 · 132 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63736-124-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63736-124-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63736-124-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63736-124-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63736-124-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63736-124-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63736-124-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63736-124-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63736-124-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63736-124-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63736-124-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63736-124-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63736-124-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63736-124-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63736-124-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63736-124-95	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63736-124-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63736-124-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63736-124-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63736-124-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63736-124-95	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63736-124-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63736-124-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63736-124-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63736-124-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63736-124-95	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63736-124-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63736-124-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63736-124-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63736-124-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63736-124-95	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63736-124-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63736-124-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63736-124-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63736-124-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63736-124-95	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63736-124-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63736-124-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63736-124-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63736-124-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63736-124-95	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63736-124-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63736-124-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63736-124-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63736-124-16	`0efc9e666f02…`	`f202fb6c5f17…`
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	63736-124-95	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63736-124-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63736-124-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63736-124-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63736-124-16	`ad56d346431e…`	`cc804d4bbf1e…`

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, Related label table
NDC	Related label
63736-124-08	BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC
63736-124-12	BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC
63736-124-16	BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC
63736-124-21	BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC
63736-124-95	BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63736-124-08	Bonine	8 in 1 BOX	TABLET, CHEWABLE	8	2
63736-124-12	Bonine	12 in 1 BOX	TABLET, CHEWABLE	12	2
63736-124-16	Bonine	16 in 1 BOX	TABLET, CHEWABLE	16	2
63736-124-21	Bonine	21 in 1 BOX	TABLET, CHEWABLE	21	2
63736-124-95	Bonine	2 in 1 POUCH	TABLET, CHEWABLE	2	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
meclizine hydrochloride	ACTIVE INGREDIENT	HDP7W44CIO	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2
meclizine	ACTIVE MOIETY	3L5TQ84570	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2
crospovidone	INACTIVE INGREDIENT	68401960MK	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63736-124	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]	2	Legacy NDC, 5 package rows	20100302_0b4b55cd-063e-4d0e-911c-8e03886e15d3.zip

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
995634	Bonine 25 MG Chewable Tablet	PSN	0b4b55cd-063e-4d0e-911c-8e03886e15d3	2
995632	meclizine HCl 25 MG Chewable Tablet	PSN	0b4b55cd-063e-4d0e-911c-8e03886e15d3	2
995634	meclizine hydrochloride 25 MG Chewable Tablet [Bonine]	SBD	0b4b55cd-063e-4d0e-911c-8e03886e15d3	2
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	0b4b55cd-063e-4d0e-911c-8e03886e15d3	2
995634	Bonine 25 MG Chewable Tablet	SY	0b4b55cd-063e-4d0e-911c-8e03886e15d3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63736-124-08	63736012408	8 in 1 BOX	Historical
63736-124-12	63736012412	12 in 1 BOX	Historical
63736-124-16	63736012416	16 in 1 BOX	Historical
63736-124-21	63736012421	21 in 1 BOX	Historical
63736-124-95	63736012495	2 in 1 POUCH	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC	Insight Pharmaceuticals	2010-01-11	HUMAN OTC DRUG LABEL	2