infants

Generic: simethicone

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name infants
Generic Name simethicone
Labeler rugby laboratories
Dosage Form SUSPENSION/ DROPS
Routes
ORAL
Active Ingredients

dimethicone, unspecified 20 mg/.3mL

Manufacturer
RUGBY LABORATORIES

Identifiers & Regulatory

Product NDC 0536-1303
Product ID 0536-1303_41f5317f-a058-f03c-e063-6394a90a321a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2020-09-01

Pharmacologic Class

Classes
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05361303
Hyphenated Format 0536-1303

Supplemental Identifiers

RxCUI
198857
UPC
0305361303754
UNII
92RU3N3Y1O

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name infants (source: ndc)
Generic Name simethicone (source: ndc)
Application Number M002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/.3mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0536-1303-75) / 30 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

0536-1303-75 1 BOTTLE, DROPPER in 1 CARTON (0536-1303-75) / 30 mL in 1 BOTTLE, DROPPER

Ingredients (1)

dimethicone, unspecified (20 mg/.3mL)

Linked Drug Pages (1)

Infants ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41f5317f-a058-f03c-e063-6394a90a321a", "openfda": {"upc": ["0305361303754"], "unii": ["92RU3N3Y1O"], "rxcui": ["198857"], "spl_set_id": ["c6fa71bc-de48-47f4-80c4-7d92643d2664"], "manufacturer_name": ["RUGBY LABORATORIES"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0536-1303-75)  / 30 mL in 1 BOTTLE, DROPPER", "package_ndc": "0536-1303-75", "marketing_start_date": "20200901"}], "brand_name": "Infants", "product_id": "0536-1303_41f5317f-a058-f03c-e063-6394a90a321a", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "0536-1303", "generic_name": "Simethicone", "labeler_name": "RUGBY LABORATORIES", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Infants", "active_ingredients": [{"name": "DIMETHICONE, UNSPECIFIED", "strength": "20 mg/.3mL"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200901", "listing_expiration_date": "20261231"}