infants

Generic: simethicone

Labeler: atlantic biologicals corp.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name infants
Generic Name simethicone
Labeler atlantic biologicals corp.
Dosage Form SUSPENSION/ DROPS
Routes
ORAL
Active Ingredients

dimethicone 20 mg/.3mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-1303
Product ID 17856-1303_3288018d-5d72-4792-e063-6294a90a2c8c
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

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178561303
Hyphenated Format 17856-1303

Supplemental Identifiers

RxCUI
198857
UNII
92RU3N3Y1O
NUI
N0000010282

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
  • 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-1) / .3 mL in 1 SYRINGE
  • 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-2) / .3 mL in 1 SYRINGE
  • 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-3) / .6 mL in 1 SYRINGE
  • 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-4) / .6 mL in 1 SYRINGE
  • 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-5) / 1.2 mL in 1 SYRINGE
source: ndc

Packages (5)

17856-1303-1 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-1) / .3 mL in 1 SYRINGE 17856-1303-2 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-2) / .3 mL in 1 SYRINGE 17856-1303-3 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-3) / .6 mL in 1 SYRINGE 17856-1303-4 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-4) / .6 mL in 1 SYRINGE 17856-1303-5 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-5) / 1.2 mL in 1 SYRINGE

Ingredients (1)

dimethicone (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": "3288018d-5d72-4792-e063-6294a90a2c8c", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["198857"], "spl_set_id": ["27fce442-e328-41d2-bab9-87ab21550c04"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-1)  / .3 mL in 1 SYRINGE", "package_ndc": "17856-1303-1", "marketing_start_date": "20210630"}, {"sample": false, "description": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-2)  / .3 mL in 1 SYRINGE", "package_ndc": "17856-1303-2", "marketing_start_date": "20210630"}, {"sample": false, "description": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-3)  / .6 mL in 1 SYRINGE", "package_ndc": "17856-1303-3", "marketing_start_date": "20210630"}, {"sample": false, "description": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-4)  / .6 mL in 1 SYRINGE", "package_ndc": "17856-1303-4", "marketing_start_date": "20210630"}, {"sample": false, "description": "60 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-5)  / 1.2 mL in 1 SYRINGE", "package_ndc": "17856-1303-5", "marketing_start_date": "20210630"}], "brand_name": "Infants", "product_id": "17856-1303_3288018d-5d72-4792-e063-6294a90a2c8c", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "17856-1303", "generic_name": "Simethicone", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Infants", "active_ingredients": [{"name": "DIMETHICONE", "strength": "20 mg/.3mL"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200901", "listing_expiration_date": "20261231"}