FDA.reportPublic FDA data

Caldesene Medicated Protecting

Product NDC
63736-306
11-digit product format
637360306
Labeler code
63736
Product ID
63736-306_954623a3-77db-4ff4-8b50-cbe143a16955
Type
HUMAN OTC DRUG
Nonproprietary name
Cornstarch and Zinc Oxide
Dosage form
POWDER
Route
TOPICAL
Labeler
Insight Pharmaceuticals LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-15
Substance
STARCH, CORN; ZINC OXIDE
Active strength
115; 21 g/142g; g/142g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Caldesene Medicated Protecting
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STARCH, CORN115 g/142g
ZINC OXIDE21 g/142g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039054Internal RxNorm lookup
1039057Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ffc92a0f-a7cf-4a46-b2f1-089df2bbb96bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-306-01Caldesene Medicated Protecting142 g in 1 BOTTLEPOWDER1426

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-306CALDESENE MEDICATED PROTECTING (CORNSTARCH AND ZINC OXIDE) POWDER [INSIGHT PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 1 package rows20240125_ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b.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 9 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
application number: M016
BABY BUM DIAPERZINC OXIDECreative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare53d8a654-aaec-6f91-e063-6394a90a73512026-06-09WarningsExact identifier
application number: M016
CELISTAR MICRONEEDLING INFUSIONHYALURONATE SODIUMGuangdong Outeli Biotechnology Co., Ltd.53de46a7-3947-70a7-e063-6294a90ab8292026-06-09WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
application number: M016
WOODSLEEP Wild Yam CreamGLYCERINShantou Woodsleep Biotechnology Co., Ltd.53b992fd-5759-57bb-e063-6394a90a16002026-06-08WarningsExact identifier
application number: M016
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
application number: M016
GNP Calamine Topical SuspensionCALAMINE 8% AND ZINC OXIDE 8%Amerisource Bergen777b0e66-1bce-4483-9dad-c46796fd6f232026-06-04WarningsExact identifier
application number: M016
GNP CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEAmerisource Bergen515c58d7-0dc4-45e7-9155-e5270a16290e2026-06-04WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company535a0e8e-6bb4-6652-e063-6394a90aa7ff2026-06-03WarningsExact identifier
application number: M016
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.535e42a1-8b14-324d-e063-6394a90a3f652026-06-03WarningsExact identifier
application number: M016
Petroleum Jelly Skin ProtectantWHITE PETROLATUMAcme United Corporation535e94bb-21e8-90be-e063-6394a90a37bb2026-06-03WarningsExact identifier
application number: M016
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
application number: M016
PUTRIZEN 40 UREAGLYCERINShantou Ximonth Biotechnology Co., Ltd.533dadbc-6f20-d880-e063-6394a90a753f2026-06-01WarningsExact identifier
application number: M016
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
application number: M016
KIEHLS SINCE 1851 Ultra Facial Meltdown RecoveryCOLLOIDAL OATMEALLOreal USA Products Inc22e088b9-b3b1-4c34-be12-a5a31200ec252026-05-29WarningsExact identifier
application number: M016
Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.53008b89-89ab-7650-e063-6294a90ac16c2026-05-29WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
application number: M016
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039057Caldesene Baby 81 % / 15 % Topical PowderPSNffc92a0f-a7cf-4a46-b2f1-089df2bbb96b6
1039054corn starch 81 % / zinc oxide 15 % Topical PowderPSNffc92a0f-a7cf-4a46-b2f1-089df2bbb96b6
1039057starch 0.81 MG/MG / zinc oxide 0.15 MG/MG Topical Powder [Caldesene]SBDffc92a0f-a7cf-4a46-b2f1-089df2bbb96b6
1039054starch 0.81 MG/MG / zinc oxide 0.15 MG/MG Topical PowderSCDffc92a0f-a7cf-4a46-b2f1-089df2bbb96b6
1039057Caldesene (starch 0.81 MG/MG / zinc oxide 0.15 MG/MG) Topical PowderSYffc92a0f-a7cf-4a46-b2f1-089df2bbb96b6
1039057Caldesene (starch 81 % / zinc oxide 15 % ) Topical PowderSYffc92a0f-a7cf-4a46-b2f1-089df2bbb96b6
1039054corn starch 81 % / zinc oxide 15 % Topical PowderSYffc92a0f-a7cf-4a46-b2f1-089df2bbb96b6
1039054Starch 0.81 MG/MG / ZNO 0.15 MG/MG Topical PowderSYffc92a0f-a7cf-4a46-b2f1-089df2bbb96b6
1039057Starch 0.81 MG/MG / ZNO 0.15 MG/MG Topical Powder [Caldesene]SYffc92a0f-a7cf-4a46-b2f1-089df2bbb96b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-306-0163736030601142 g in 1 BOTTLE (63736-306-01) 142 g2017-07-150000-00-00NoNoCurrent