FDA.reportPublic FDA data

BioDCream

Manufacturer
Advanced Generic Corporation
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:47:36

Label at a glance#

ProductBioDCream
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

Change wet or soiled diaper promptly Cleanse the diaper area and allow to dry Apply Cream liberally as often as necessary, with each diaper change, especially at bedtime or when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.25%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

For external use only. 

  • When using this product avoid contact with eyes.
  • Stop use and ask doctor if condition worsens or lasts more than 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Change wet or soiled diaper promptly
  • Cleanse the diaper area and allow to dry
  • Apply Cream liberally as often as necessary, with each diaper change, especially at bedtime or when exposure to wet diapers may be prolonged.

Inactive ingredients

INACTIVE INGREDIENT SECTION

beeswax, butylated hydroxyl anisole, diazolidinyl urea, lanolin oil, lavender fragrance, methylparaben, paraffinum liquidum, propylene glycol, propylparaben, white petrolatum.

Questions or comments:

OTC - QUESTIONS SECTION

1-305-403-3788

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioDcreamBioDcream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1793915zinc oxide 15.25 % Topical CreamPSN7
1793915zinc oxide 153 MG/ML Topical CreamSCD7
1793915zinc oxide 15.25 % Topical CreamSY7
1793915ZNO 153 MG/ML Topical CreamSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-701-042020-12-23C16284748780-19d75b9d0-81bb-f424-e053-dadaa90a57ceAGC-BioDCream 701
45737-701-042020-01-31C16284748780-19d75b9d0-81bb-f424-e053-dadaa90a57ceAGC-BioDCream 701

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-701-04BioDCream125 g in 1 JARCREAM1257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-701BIODCREAM (ZINC OXIDE) CREAM [ADVANCED GENERIC CORPORATION]7Legacy NDC, 1 package rows20241222_89a3a755-0928-471b-95ed-8b07d08e4675.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-701-04GM - Gram45737-70157c7d751-74b8-4c0a-8463-0e1997f521c912025-07-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45737-70145737-701-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
MINERAL OILT5L8T28FGPIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
LANOLIN OILOVV5IIJ58FIACT
PETROLATUM4T6H12BN9UIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
29bbf687-991b-352a-e063-6394a90a72b389a3a755-0928-471b-95ed-8b07d08e46752024-12-20WarningsExact identifier
spl id: 29bbf687-991b-352a-e063-6394a90a72b3
spl set id: 89a3a755-0928-471b-95ed-8b07d08e4675

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.