Infants Non-staining Gas relief

Product NDC: 37808-014
11-digit product format: 378080014
Labeler code: 37808
Product ID: 37808-014_aaa20f93-6044-4e3e-8757-9e73a9701932
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: SOLUTION/ DROPS
Route: ORAL
Labeler: H E B
Application: part332
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-11-15
Substance: DIMETHICONE
Active strength: 20 mg/.3mL
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Infants Non-staining Gas relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	20 mg/.3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	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
99d94de2-9550-4d2d-99d4-1be0ef7b7880	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37808-014-09	Infants Non-staining Gas relief	1 in 1 CARTON	SOLUTION/ DROPS	1		2
37808-014-09	Infants Non-staining Gas relief	30 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-014	INFANTS NON-STAINING GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [H E B]	2	Current NDC, Legacy NDC, 2 package rows	20231205_99d94de2-9550-4d2d-99d4-1be0ef7b7880.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
Infants Non-staining Gas relief	SIMETHICONE	H E B	99d94de2-9550-4d2d-99d4-1be0ef7b7880	2023-12-04	Warnings	Exact identifier ndc (product): 37808-014

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-014-09	37808001409	1 BOTTLE, DROPPER in 1 CARTON (37808-014-09) / 30 mL in 1 BOTTLE, DROPPER	2021-11-15	0000-00-00	No	No	Current