retin-a

Generic: tretinoin

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name retin-a
Generic Name tretinoin
Labeler bausch health us, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

tretinoin .5 mg/g

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 0187-5162
Product ID 0187-5162_18a7b6d8-e3c4-676f-e063-6294a90a0498
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017522
Listing Expiration 2026-12-31
Marketing Start 1974-07-30

Pharmacologic Class

Established (EPC)
retinoid [epc]
Chemical Structure
retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01875162
Hyphenated Format 0187-5162

Supplemental Identifiers

RxCUI
106302 106303 198300 208328 208330 208331 208334 313450 313451 701305
UPC
0301875170455 0301875172459
UNII
5688UTC01R
NUI
N0000175607 M0018962

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 retin-a (source: ndc)
Generic Name tretinoin (source: ndc)
Application Number NDA017522 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0187-5162-20) / 20 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0187-5162-45) / 45 g in 1 TUBE
source: ndc

Packages (2)

0187-5162-20 1 TUBE in 1 CARTON (0187-5162-20) / 20 g in 1 TUBE 0187-5162-45 1 TUBE in 1 CARTON (0187-5162-45) / 45 g in 1 TUBE

Ingredients (1)

tretinoin (.5 mg/g)

Linked Drug Pages (1)

Retin-A ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "18a7b6d8-e3c4-676f-e063-6294a90a0498", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0301875170455", "0301875172459"], "unii": ["5688UTC01R"], "rxcui": ["106302", "106303", "198300", "208328", "208330", "208331", "208334", "313450", "313451", "701305"], "spl_set_id": ["9556d73d-c573-4e0a-9feb-764ce2d1107b"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0187-5162-20)  / 20 g in 1 TUBE", "package_ndc": "0187-5162-20", "marketing_start_date": "19740730"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0187-5162-45)  / 45 g in 1 TUBE", "package_ndc": "0187-5162-45", "marketing_start_date": "19740730"}], "brand_name": "Retin-A", "product_id": "0187-5162_18a7b6d8-e3c4-676f-e063-6294a90a0498", "dosage_form": "CREAM", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0187-5162", "generic_name": "Tretinoin", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Retin-A", "active_ingredients": [{"name": "TRETINOIN", "strength": ".5 mg/g"}], "application_number": "NDA017522", "marketing_category": "NDA", "marketing_start_date": "19740730", "listing_expiration_date": "20261231"}