balmex diaper rash

Generic: zinc oxide 11.3%

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

Drug Facts

Product Profile

Brand Name balmex diaper rash
Generic Name zinc oxide 11.3%
Labeler randob labs, ltd
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

zinc oxide 11.3 g/100g

Manufacturer
Randob Labs, LTD

Identifiers & Regulatory

Product NDC 52412-285
Product ID 52412-285_29577ef9-f215-1dc6-e063-6394a90a44ab
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2021-04-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52412285
Hyphenated Format 52412-285

Supplemental Identifiers

RxCUI
630923 967558
UPC
0030103042003
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 11.3% (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 11.3 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (52412-285-02) / 56 g in 1 TUBE
  • 1 TUBE in 1 CARTON (52412-285-03) / 85 g in 1 TUBE
  • 1 TUBE in 1 CARTON (52412-285-04) / 113 g in 1 TUBE
  • 340 g in 1 JAR (52412-285-12)
  • 453 g in 1 JAR (52412-285-16)
source: ndc

Packages (5)

52412-285-02 1 TUBE in 1 CARTON (52412-285-02) / 56 g in 1 TUBE 52412-285-03 1 TUBE in 1 CARTON (52412-285-03) / 85 g in 1 TUBE 52412-285-04 1 TUBE in 1 CARTON (52412-285-04) / 113 g in 1 TUBE 52412-285-12 340 g in 1 JAR (52412-285-12) 52412-285-16 453 g in 1 JAR (52412-285-16)

Ingredients (1)

zinc oxide (11.3 g/100g)

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": "29577ef9-f215-1dc6-e063-6394a90a44ab", "openfda": {"upc": ["0030103042003"], "unii": ["SOI2LOH54Z"], "rxcui": ["630923", "967558"], "spl_set_id": ["f7f7a89d-d4e0-9faa-e053-6294a90aaf7b"], "manufacturer_name": ["Randob Labs, LTD"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (52412-285-02)  / 56 g in 1 TUBE", "package_ndc": "52412-285-02", "marketing_start_date": "20210419"}, {"sample": false, "description": "1 TUBE in 1 CARTON (52412-285-03)  / 85 g in 1 TUBE", "package_ndc": "52412-285-03", "marketing_start_date": "20230404"}, {"sample": false, "description": "1 TUBE in 1 CARTON (52412-285-04)  / 113 g in 1 TUBE", "package_ndc": "52412-285-04", "marketing_start_date": "20210419"}, {"sample": false, "description": "340 g in 1 JAR (52412-285-12)", "package_ndc": "52412-285-12", "marketing_start_date": "20210419"}, {"sample": false, "description": "453 g in 1 JAR (52412-285-16)", "package_ndc": "52412-285-16", "marketing_start_date": "20210419"}], "brand_name": "Balmex Diaper Rash", "product_id": "52412-285_29577ef9-f215-1dc6-e063-6394a90a44ab", "dosage_form": "CREAM", "product_ndc": "52412-285", "generic_name": "Zinc Oxide 11.3%", "labeler_name": "Randob Labs, LTD", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Balmex Diaper Rash", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "11.3 g/100g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210419", "listing_expiration_date": "20261231"}