Meclizine HCL 12.5 mg

Product NDC: 17714-117
11-digit product format: 177140117
Labeler code: 17714
Product ID: 17714-117_5cc9755e-6d41-fa9f-e053-2991aa0afbef
Type: HUMAN OTC DRUG
Nonproprietary name: Meclizine HCL 12.5 mg
Dosage form: TABLET
Route: ORAL
Labeler: Advance Pharmaceutical Inc.
Application: part336
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-07-01
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

Additional Listing Data#

Finished product: Yes
Brand name base: Meclizine HCL 12.5 mg
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
76efad7e-e765-430f-9232-63553d02f2c5	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17714-117-01	Meclizine HCL 12.5 mg	100 in 1 BOTTLE	TABLET	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17714-117	MECLIZINE HCL 12.5 MG TABLET [ADVANCE PHARMACEUTICAL INC.]	2	Current NDC, Legacy NDC, 1 package rows	20171031_76efad7e-e765-430f-9232-63553d02f2c5.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine HCL 12.5 mg	MECLIZINE HCL 12.5 MG	Advance Pharmaceutical Inc.	76efad7e-e765-430f-9232-63553d02f2c5	2017-10-30	Warnings	Exact identifier ndc (product): 17714-117

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	76efad7e-e765-430f-9232-63553d02f2c5	2
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	76efad7e-e765-430f-9232-63553d02f2c5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17714-117-01	17714011701	100 TABLET in 1 BOTTLE (17714-117-01)	100 tablet	2013-07-01	0000-00-00	No	No	Current