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#

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 37 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THE ZOEUN SKIN TOTAL CARECOLLOIDAL OATMEAL, STURGEON EXTRACTSturgeonbio Co.,Ltd.42712685-64d4-0170-e063-6394a90a75d72025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Total CleanserCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4275eecd-67bb-fb1c-e063-6294a90aa09a2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Mist TonerCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42766f41-74bc-d19d-e063-6294a90aba532025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Y-Zone Feminine MoisturizerCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42773426-f39f-bebe-e063-6394a90a73d92025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Eye CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42792a80-555b-e86c-e063-6294a90a2f302025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Night MaskCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42843691-8761-3f32-e063-6394a90a59bc2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Nourishing CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42849f5c-a983-c3ce-e063-6394a90a2fb52025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Body WashCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4285320a-bf0b-915d-e063-6394a90a9cfd2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon GelCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42859de3-15dd-c7b9-e063-6394a90af5012025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Hair EssenceCOLLOIDAL OATMAELSturgeonbio Co.,Ltd.4285eb13-d1a2-0663-e063-6294a90ac40f2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Total Care CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.428643c3-e932-4db5-e063-6294a90ac36c2025-10-01WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEGeri-Gentle Corporationf5cfab62-8aab-4109-b15b-4fe380f7cb9e2025-09-29WarningsExact identifier
application number: M016
GoodSense Petroleum JellyWHITE PETROLATUMGOOD SENSE3492f044-250e-45f7-8638-e3c55713e0f52025-09-29WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC2a028465-1dff-4ae7-abf6-7521c2784dd12025-09-26WarningsExact identifier
application number: M016
Johnsons Baby First Touch Gift SetZINC OXIDEKenvue Brands LLC3f838eb7-42a3-c96b-e063-6294a90a74912025-09-26WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly OriginalWHITE PETROLATUMVeridian Healthcare1fb96a6c-7d13-4ccf-8fa6-55ec79e6877c2025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Baby FreshWHITE PETROLATUMVeridian Healthcare0d3e6c1a-3ba9-4442-bae0-27312d658d072025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Cocoa ButterWHITE PETROLATUMVeridian Healthcare5c7d9eb6-c129-4fd9-9671-2e0f0453fd282025-09-25WarningsExact identifier
application number: M016
SKIN TAG REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD3ee79d66-e728-48dd-e063-6394a90a64632025-09-16WarningsExact identifier
application number: M016
ProCure LanaCareLANOLIN 50%Twin Med LLC3aabd4ea-107c-a02c-e063-6294a90aee072025-09-15WarningsExact 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