balmex diaper rash

Generic: zinc oxide

Labeler: randob labs,ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name balmex diaper rash
Generic Name zinc oxide
Labeler randob labs,ltd.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

zinc oxide .113 g/g

Manufacturer
Randob Labs,Ltd.

Identifiers & Regulatory

Product NDC 52412-400
Product ID 52412-400_18af2fdd-d234-4675-afc6-e0bdd19cdbbd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part347
Listing Expiration 2026-12-31
Marketing Start 2015-04-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52412400
Hyphenated Format 52412-400

Supplemental Identifiers

RxCUI
630923 967558
UNII
SOI2LOH54Z

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 balmex diaper rash (source: ndc)
Generic Name zinc oxide (source: ndc)
Application Number part347 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .113 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (52412-400-02) / 56 g in 1 TUBE
  • 1 TUBE in 1 CARTON (52412-400-04) / 113 g in 1 TUBE
  • 5.1 g in 1 PACKAGE (52412-400-05)
  • 453 g in 1 JAR (52412-400-16)
source: ndc

Packages (4)

52412-400-02 1 TUBE in 1 CARTON (52412-400-02) / 56 g in 1 TUBE 52412-400-04 1 TUBE in 1 CARTON (52412-400-04) / 113 g in 1 TUBE 52412-400-05 5.1 g in 1 PACKAGE (52412-400-05) 52412-400-16 453 g in 1 JAR (52412-400-16)

Ingredients (1)

zinc oxide (.113 g/g)

Linked Drug Pages (1)

Balmex Diaper Rash ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "18af2fdd-d234-4675-afc6-e0bdd19cdbbd", "openfda": {"unii": ["SOI2LOH54Z"], "rxcui": ["630923", "967558"], "spl_set_id": ["f202dd0e-7c61-4ea1-a5f6-e90898366ba3"], "manufacturer_name": ["Randob Labs,Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (52412-400-02)  / 56 g in 1 TUBE", "package_ndc": "52412-400-02", "marketing_start_date": "20181101"}, {"sample": false, "description": "1 TUBE in 1 CARTON (52412-400-04)  / 113 g in 1 TUBE", "package_ndc": "52412-400-04", "marketing_start_date": "20181101"}, {"sample": false, "description": "5.1 g in 1 PACKAGE (52412-400-05)", "package_ndc": "52412-400-05", "marketing_start_date": "20181101"}, {"sample": false, "description": "453 g in 1 JAR (52412-400-16)", "package_ndc": "52412-400-16", "marketing_start_date": "20181101"}], "brand_name": "Balmex Diaper Rash", "product_id": "52412-400_18af2fdd-d234-4675-afc6-e0bdd19cdbbd", "dosage_form": "CREAM", "product_ndc": "52412-400", "generic_name": "Zinc Oxide", "labeler_name": "Randob Labs,Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Balmex Diaper Rash", "active_ingredients": [{"name": "ZINC OXIDE", "strength": ".113 g/g"}], "application_number": "part347", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20150427", "listing_expiration_date": "20261231"}