Gripe Water

Product NDC: 64616-119
11-digit product format: 646160119
Labeler code: 64616
Product ID: 64616-119_462f6fc3-ff7b-4849-e063-6294a90a28f9
Type: HUMAN OTC DRUG
Nonproprietary name: Gripe Water
Dosage form: LIQUID
Route: ORAL
Labeler: Vitality Works
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2017-01-31
Substance: MATRICARIA CHAMOMILLA WHOLE; MENTHA PIPERITA; ZINGIBER OFFICINALE WHOLE; FOENICULUM VULGARE VAR. VULGARE WHOLE
Active strength: 1; 1; 1; 1 [hp_X]/.0025mL; [hp_X]/.0025mL; [hp_X]/.0025mL; [hp_X]/.0025mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Gripe Water
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MATRICARIA CHAMOMILLA WHOLE	1 [hp_X]/.0025mL
MENTHA PIPERITA	1 [hp_X]/.0025mL
ZINGIBER OFFICINALE WHOLE	1 [hp_X]/.0025mL
FOENICULUM VULGARE VAR. VULGARE WHOLE	1 [hp_X]/.0025mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G0R4UBI2ZZ	Internal UNII lookup
79M2M2UDA9	Internal UNII lookup
IN6Q3S3414	Internal UNII lookup
J1UK54JBGH	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
45ade734-f446-4370-e054-00144ff88e88	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64616-119-01	Gripe Water	59.1 mL in 1 BOTTLE, DROPPER	LIQUID	59.1		7
64616-119-02	Gripe Water	1 in 1 CARTON	LIQUID	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64616-119	GRIPE WATER LIQUID [VITALITY WORKS]	6	Current NDC, Legacy NDC, 2 package rows	20241212_45ade734-f446-4370-e054-00144ff88e88.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
Gripe Water	GRIPE WATER	Vitality Works	45ade734-f446-4370-e054-00144ff88e88	2025-12-17	Warnings	Exact identifier ndc (product): 64616-119

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
79M2M2UDA9	MENTHA PIPERITA	MENTHA PIPERITA
IN6Q3S3414	ZINGIBER OFFICINALE WHOLE	ZINGIBER OFFICINALE WHOLE
R9S0526LYO	FOENICULUM VULGARE VAR. VULGARE WHOLE	FOENICULUM VULGARE VAR. VULGARE WHOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64616-119-01	64616011901	59.1 mL in 1 BOTTLE, DROPPER	59.1 ml					Historical
64616-119-02	64616011902	1 BOTTLE, DROPPER in 1 CARTON (64616-119-02) / 59.1 mL in 1 BOTTLE, DROPPER (64616-119-01)		2017-08-29	0000-00-00	No	No	Current