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 34 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ODLUMIVIE Salmon DNA Repairing SerumRH-OLIGOPEPTIDE-1ODLUMIVIE435ecb5b-0d12-4da1-e063-6394a90a8be22025-11-11WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMKROGER3feb1346-76b6-fbb6-e063-6394a90a17d12025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Ceramide ReviCell CreamCERAMIDE NPODLUMIVIE435ee48f-1b9e-6d08-e063-6394a90af5b52025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Dendrobium Restorative MaskDENDROBIUM OFFICINALE STEMODLUMIVIE435ef0e0-50be-c4e4-e063-6294a90a8e8e2025-11-11WarningsExact identifier
application number: M016
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
application number: M016
TATWAX VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.333fdce4-5a1d-45a4-94fe-81d47ecd26702025-11-07WarningsExact identifier
application number: M016
Arme Scar GelDIMETHICONENanjing Ludejin Corporation Management Co., Ltd42e9a59a-480e-f74a-e063-6294a90a06402025-11-06WarningsExact identifier
application number: M016
Baby Diaper Rash CreamZINC OXIDEHello Bello42f14aa6-5694-7727-e063-6294a90a09f32025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Classic EssenceNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1e874ac0-a993-be9e-e063-6394a90af4242025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Eye CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eeb9c36-5bd8-ec90-e063-6294a90ae4e12025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair SerumNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eb08f86-eb2a-7f29-e063-6294a90a05162025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Moisturizing CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eec4cfe-d5a3-3570-e063-6294a90ac38b2025-11-06WarningsExact identifier
application number: M016
Spa Dry Heel Foot ReliefDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a92025-11-05WarningsExact identifier
application number: M016
Royal Jelly Berry Powerful Lip CareDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.09323fbe-76b5-48c6-80a7-c35b64110a7d2025-11-05WarningsExact identifier
application number: M016
Pink Eczema CreamCOLLOIDAL OATMEALMOOGOO SKIN CARE PTY LTD3b8d92d0-ab7f-8dd5-e063-6394a90aa3af2025-11-04WarningsExact identifier
application number: M016
MedlineZINC OXIDE, PETROLATUMMedline Industries, LPf162b1a8-65b3-13a8-e053-2a95a90a3f132025-11-04WarningsExact identifier
application number: M016
MedlinePETROLATUMMedline Industries, LPf3062b61-e4c4-9f57-e053-2995a90aa0282025-11-04WarningsExact identifier
application number: M016
Sandra Plasencia Dendrobium Officinale Soothing Biofermented MaskTITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.3cdf06f2-63f2-7a59-e063-6294a90a72ea2025-11-03WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELPremier Brands of America Inc.38583c02-497b-922c-e063-6294a90a49de2025-11-03WarningsExact identifier
application number: M016
The Zoeun Omega SerumCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4277da80-b55b-74af-e063-6394a90af3252025-10-31WarningsExact 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