american safety and first aid

Generic: hydrocortisone acetate

Labeler: orazen inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name american safety and first aid
Generic Name hydrocortisone acetate
Labeler orazen inc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone acetate 10 mg/g

Manufacturer
Orazen Inc

Identifiers & Regulatory

Product NDC 71927-031
Product ID 71927-031_479b997e-a604-56a8-e063-6294a90adc70
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2027-12-31
Marketing Start 2025-12-11

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71927031
Hyphenated Format 71927-031

Supplemental Identifiers

RxCUI
106258
UNII
3X7931PO74

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 american safety and first aid (source: ndc)
Generic Name hydrocortisone acetate (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 25 POUCH in 1 BOX (71927-031-02) / .9 g in 1 POUCH (71927-031-01)
  • 144 POUCH in 1 BOX (71927-031-03) / .9 g in 1 POUCH (71927-031-01)
source: ndc

Packages (2)

71927-031-02 25 POUCH in 1 BOX (71927-031-02) / .9 g in 1 POUCH (71927-031-01) 71927-031-03 144 POUCH in 1 BOX (71927-031-03) / .9 g in 1 POUCH (71927-031-01)

Ingredients (1)

hydrocortisone acetate (10 mg/g)

Linked Drug Pages (1)

American Safety and First Aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "479b997e-a604-56a8-e063-6294a90adc70", "openfda": {"unii": ["3X7931PO74"], "rxcui": ["106258"], "spl_set_id": ["4a543f90-d43c-4487-b27e-f43394c6320d"], "manufacturer_name": ["Orazen Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 POUCH in 1 BOX (71927-031-02)  / .9 g in 1 POUCH (71927-031-01)", "package_ndc": "71927-031-02", "marketing_start_date": "20251211"}, {"sample": false, "description": "144 POUCH in 1 BOX (71927-031-03)  / .9 g in 1 POUCH (71927-031-01)", "package_ndc": "71927-031-03", "marketing_start_date": "20251211"}], "brand_name": "American Safety and First Aid", "product_id": "71927-031_479b997e-a604-56a8-e063-6294a90adc70", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71927-031", "generic_name": "HYDROCORTISONE ACETATE", "labeler_name": "Orazen Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "American Safety and First Aid", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "10 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251211", "listing_expiration_date": "20271231"}