Infants Non staining Gas relief

Product NDC
72476-520
11-digit product format
724760520
Labeler code
72476
Product ID
72476-520_1501bee6-4734-4836-8573-54af919d4221
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
Retail Business Services, LLC.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-27
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
IngredientStrength
DIMETHICONE20 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-520-09Infants Non staining Gas relief1 in 1 CARTONSOLUTION/ DROPS11
72476-520-09Infants Non staining Gas relief30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-520INFANTS NON STAINING GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [RETAIL BUSINESS SERVICES, LLC.]1Current NDC, 2 package rows20250305_1501bee6-4734-4836-8573-54af919d4221.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72476-520-09724760520091 BOTTLE, DROPPER in 1 CARTON (72476-520-09) / 30 mL in 1 BOTTLE, DROPPER2025-02-27NoNoHistorical