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 16 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty FAB Ultra Repair Body Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company1a9d86fc-ef32-baed-e063-6394a90a7d742026-03-12WarningsExact identifier
application number: M016
Meijer Scar GelALLANTOIN 0.5%Meijer4c108c34-72f3-1382-e063-6394a90a7f2c2026-03-11WarningsExact identifier
application number: M016
E2 hand washE2 SANITIZING HAND SOAPHorizon Tool Inc.a40afa46-a07d-f864-e053-2a95a90aef8a2026-03-11WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar CookieCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4576cd28-9530-4db4-e063-6394a90a9fd32026-03-10WarningsExact identifier
application number: M016
Diaper RashZINC OXIDELidl US, LLCe399b33f-5f7c-47eb-8e9b-1721ae4680b52026-03-10Warnings, Adverse reactionsExact identifier
application number: M016
Vitamin A DWHITE PETROLATUMSion Biotext Medical Ltd.503c4ab9-1f60-48e2-af47-7ef996466a5b2026-03-09WarningsExact identifier
application number: M016
TrstayRETINOL SERUMShenzhen yuehaotong Technology Co.,Ltd4c6e20dd-0a71-a96b-e063-6294a90ab8332026-03-07WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c89fc6-016b-d359-e063-6394a90a56022026-03-06WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a2026-03-06WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin ProtectantDIMETHICONEThe Procter & Gamble Manufacturing Company276c68d4-e273-4e48-e063-6294a90ab16f2026-03-04WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4c1d00b3-313b-933f-e063-6294a90ac46f2026-03-03WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEAmazon.com Services LLC495fffd7-7b64-954a-e063-6394a90a81fd2026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLAmazon.com Services LLCaceb0b10-8c90-4a06-8c47-cd1a2b4676a32026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELAmazon.com Services LLC134e07a1-5236-4088-baf9-1ff33126f7932026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEOld East Main Co.7f56ab98-dbd8-412a-8c31-bb6302b7f3292026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMOld East Main Co.ae8583c0-1b52-461d-8506-ec7524f1b4c42026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Healing for BabiesPETROLATUMOld East Main Co.aa1acc24-56af-4708-bf76-23d4de3d089e2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMOld East Main Co.de8d8071-ecb2-4719-8c7b-7944f27810d62026-03-02Warnings, Adverse reactionsExact 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