FDA.reportPublic FDA data

Caldesene Baby

Product NDC
63736-305
11-digit product format
637360305
Labeler code
63736
Product ID
63736-305_8fd854c9-b6c2-4991-a592-4d102ca0ecf9
Type
HUMAN OTC DRUG
Nonproprietary name
Starch, Corn and Zinc Oxide
Dosage form
POWDER
Route
TOPICAL
Labeler
Insight Pharmaceuticals LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-07-07
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 Baby
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
9f12dee2-7afa-45e9-a729-0fd42bb77715Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-305-05Caldesene Baby142 g in 1 BOTTLE, DISPENSINGPOWDER1426

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Starch, CornACTIVE INGREDIENTO8232NY3SJCALDESENE BABY (STARCH, CORN AND ZINC OXIDE) POWDER [INSIGHT PHARMACEUTICALS]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZCALDESENE BABY (STARCH, CORN AND ZINC OXIDE) POWDER [INSIGHT PHARMACEUTICALS]1
Starch, CornACTIVE MOIETYO8232NY3SJCALDESENE BABY (STARCH, CORN AND ZINC OXIDE) POWDER [INSIGHT PHARMACEUTICALS]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZCALDESENE BABY (STARCH, CORN AND ZINC OXIDE) POWDER [INSIGHT PHARMACEUTICALS]1
KaolinINACTIVE INGREDIENT24H4NWX5COCALDESENE BABY (STARCH, CORN AND ZINC OXIDE) POWDER [INSIGHT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-305CALDESENE BABY (STARCH, CORN AND ZINC OXIDE) POWDER [INSIGHT PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 1 package rows20240125_9f12dee2-7afa-45e9-a729-0fd42bb77715.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 68 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.5378d653-702d-405c-a067-882554aaf93a2023-08-21WarningsExact identifier
application number: M016
Quality Choice Anti-itch MedicatedCALAMINE AND PRAMOXINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5e07f26f-cfb6-57f9-e053-2991aa0a20082023-08-02WarningsExact identifier
application number: M016
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
application number: M016
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
application number: M016
Badger After-BUG BalmCOLLOIDAL OATMEALW.S. Badger Company, Inc.a623da47-cef2-146f-e053-2a95a90afe3a2021-11-17WarningsExact identifier
application number: M016
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
application number: M016
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039057Caldesene Baby 81 % / 15 % Topical PowderPSN9f12dee2-7afa-45e9-a729-0fd42bb777156
1039054corn starch 81 % / zinc oxide 15 % Topical PowderPSN9f12dee2-7afa-45e9-a729-0fd42bb777156
1039057starch 0.81 MG/MG / zinc oxide 0.15 MG/MG Topical Powder [Caldesene]SBD9f12dee2-7afa-45e9-a729-0fd42bb777156
1039054starch 0.81 MG/MG / zinc oxide 0.15 MG/MG Topical PowderSCD9f12dee2-7afa-45e9-a729-0fd42bb777156
1039057Caldesene (starch 0.81 MG/MG / zinc oxide 0.15 MG/MG) Topical PowderSY9f12dee2-7afa-45e9-a729-0fd42bb777156
1039057Caldesene (starch 81 % / zinc oxide 15 % ) Topical PowderSY9f12dee2-7afa-45e9-a729-0fd42bb777156
1039054corn starch 81 % / zinc oxide 15 % Topical PowderSY9f12dee2-7afa-45e9-a729-0fd42bb777156
1039054Starch 0.81 MG/MG / ZNO 0.15 MG/MG Topical PowderSY9f12dee2-7afa-45e9-a729-0fd42bb777156
1039057Starch 0.81 MG/MG / ZNO 0.15 MG/MG Topical Powder [Caldesene]SY9f12dee2-7afa-45e9-a729-0fd42bb777156

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-305-0563736030505142 g in 1 BOTTLE, DISPENSING (63736-305-05) 142 g2009-07-070000-00-00NoNoCurrent