FDA.reportPublic FDA data

Medicated Cornstarch Baby Powder

Product NDC
42669-231
11-digit product format
426690231
Labeler code
42669
Product ID
42669-231_8e64a51a-f760-498c-81d2-40be7ff55478
Type
HUMAN OTC DRUG
Nonproprietary name
Active Corn Starch
Dosage form
POWDER
Route
TOPICAL
Labeler
Davion, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-01
Substance
STARCH, CORN; ZINC OXIDE; KAOLIN
Active strength
89.27; 16.95; 4.52 g/113g; g/113g; g/113g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Medicated Cornstarch Baby Powder
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STARCH, CORN89.27 g/113g
ZINC OXIDE16.95 g/113g
KAOLIN4.52 g/113g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O8232NY3SJInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
24H4NWX5COInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1361201Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e39032d1-c8cd-4a41-af10-126970b8ad38Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42669-231-042024-02-28C16284748780-11030e365-312c-111a-e063-dadaa90a10e2Medicated Cornstarch Baby Powder
42669-231-042024-01-30C16284748780-11030e365-312c-111a-e063-dadaa90a10e2Medicated Cornstarch Baby Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42669-231-04Medicated Cornstarch Baby Powder113 g in 1 BOXPOWDER1134

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42669-231MEDICATED CORNSTARCH BABY POWDER (ACTIVE CORN STARCH) POWDER [DAVION, INC.]3Current NDC, Legacy NDC, 1 package rows20240229_e39032d1-c8cd-4a41-af10-126970b8ad38.zip

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 5 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
application number: M016
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
application number: M016
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
application number: M016
DermasporinLANOLINMarie's Original Formulas LLC562f40aa-eeec-2b7c-e063-6294a90ad68d2026-07-22WarningsExact identifier
application number: M016
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
application number: M016
DermactLANOLINMarie's Original Formulas LLC57121dbe-e886-a562-e063-6294a90a367f2026-07-22WarningsExact identifier
application number: M016
Universal WITCH HAZELWITCH HAZELUniversal Distribution Center LLC7e0b56ef-fa41-4862-b387-5b58d81d67d42026-07-22WarningsExact identifier
application number: M016
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
application number: M016
DERMFREE SCAR SHEETSSILICONE GEL 1% SCAR SHEETSJiangxi Yudexi Pharmaceutical Co., LTD4a4ce316-4b92-7e81-e063-6294a90af6db2026-07-21WarningsExact identifier
application number: M016
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
application number: M016
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
application number: M016
DoveMEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BARConopco d/b/a Unilever56bd6fcb-c762-4e5a-e063-6394a90a34382026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINPMI Branded Pharmaceuticals, Inc.25bc1eae-3502-4c63-bd8a-43be2dfb0d6d2026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINL. Perrigo Company9c3d9e08-9428-4b28-82a2-0cb24c3c92a32026-07-16WarningsExact identifier
application number: M016
aftershaveCERAMIDE NPShengnan (Guangzhou) Cosmetics Co., LTD56a17ac9-803b-932c-e063-6394a90aae902026-07-15WarningsExact identifier
application number: M016
Clear Root Labs Wound CareCRL WOUND CARE OINTMENTAidance Scientific Inc. DBA Aidance Skincare & Topicals56a6dbc7-5001-c095-e063-6294a90a1aa02026-07-15WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361201cornstarch 79 % / kaolin 4 % / zinc oxide 15 % Topical PowderPSNe39032d1-c8cd-4a41-af10-126970b8ad384
1361201corn starch 0.79 MG/MG / kaolin 0.04 MG/MG / zinc oxide 0.15 MG/MG Topical PowderSCDe39032d1-c8cd-4a41-af10-126970b8ad384
1361201corn starch 0.79 MG/MG / Kaolin 0.04 MG/MG / ZNO 0.15 MG/MG Topical PowderSYe39032d1-c8cd-4a41-af10-126970b8ad384
1361201cornstarch 79 % / kaolin 4 % / zinc oxide 15 % Topical PowderSYe39032d1-c8cd-4a41-af10-126970b8ad384

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42669-231-0442669023104113 g in 1 BOX (42669-231-04) 113 g2016-09-010000-00-00NoNoCurrent