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 23 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pure petroleumWHITE PETROLATUMRite Aid Corporationf67be4cc-9983-4758-93c8-383919ec07ca2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMRite Aid Corporation0d535736-ba61-42eb-9112-c154295372a22026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec67a1ee-ad71-54f2-e053-2995a90a76902026-01-29WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUM7-Select7e93df71-74bd-4d95-9a64-54756c7b234a2026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
TheraCare Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare49132a75-4a16-cede-e063-6294a90a62172026-01-29WarningsExact identifier
application number: M016
TheraCare A and DLANOLIN, PETROLATUMVeridian Healthcare1303aa33-2111-b36c-e063-6294a90af1312026-01-29WarningsExact identifier
application number: M016
Zinc oxideZINC OXIDEAldi, Incd56782c1-b23c-47a9-82cb-d7dbb0ac7aa32026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAldi, Inc94fea2f2-fea8-4923-afc6-36068bc2fef52026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
DAILY MOISTURIZINGDIMETHICONE LOTIONAldi, Inc4ad18f4a-e148-4bf5-a04b-4168fa48eeb22026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALAldi, Inc79f498af-c207-4f85-bf1b-fb2ee8379fd82026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC066b1313-aed8-9436-e063-6294a90a2b112026-01-29WarningsExact identifier
application number: M016
Equate Scar TopicalALLANTOINWalMartcf511a02-355c-4286-82fa-6f0c4a2448232026-01-29WarningsExact identifier
application number: M016
TriDerma Stubborn Diaper Rash ReliefALLANTOIN, DIMETHICONEGenuine Virgin Aloe Corporationf8f3ae0b-aa55-4c2f-8823-54268524917b2026-01-28WarningsExact identifier
application number: M016
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M016
Equate Chafing GelDIMETHICONEWalmart Inc06665504-040c-a806-e063-6294a90acedc2026-01-27WarningsExact identifier
application number: M016
Body Oil for Stretch MarksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILDongguan Xiaogoubeige trading company Ltd.496af9a1-7249-622f-e063-6394a90aa2842026-01-27WarningsExact identifier
application number: M016
Herpecin LZINC OXIDE, DIMETHICONEFocus Consumer Healthcare, LLC488a29c3-dd97-af1a-e063-6394a90aba7f2026-01-26WarningsExact identifier
application number: M016
XIMONTH Nail Nourishing PenGLYCERINShantou Ximonth Biotechnology Co., Ltd.49451717-e41c-8ae0-e063-6294a90a91ad2026-01-26WarningsExact identifier
application number: M016
Kerasal Athletes Foot Rapid Symptom Relief Medicated SoakALUMINUM SULFATE TETRADECAHYDRATE AND CALCIUM ACETATE MONOHYDRATEAdvantice Health, LLC.09a178c1-0eb1-43e5-bde8-fd27ed633d592026-01-26WarningsExact 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