FDA.reportPublic FDA data

Botao Baby Diaper Rash Cream

Product NDC
69435-1501
11-digit product format
694351501
Labeler code
69435
Product ID
69435-1501_48300ffa-cb19-1829-e063-6294a90a3054
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Peer Pharm Ltd.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-19
Substance
ZINC OXIDE
Active strength
9 g/71g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Botao Baby Diaper Rash Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE9 g/71g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df60a70e-e6c0-41b3-e053-2995a90af176Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69435-1501-22024-01-31C16284748780-11030e365-2669-111a-e063-dadaa90a10e2Botao Baby Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1501-1Botao Baby Diaper Rash Cream70.8 g in 1 TUBE, WITH APPLICATORCREAM70.83
69435-1501-2Botao Baby Diaper Rash Cream1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1501BOTAO BABY DIAPER RASH CREAM (ZINC OXIDE) CREAM [PEER PHARM LTD.]2Current NDC, Legacy NDC, 2 package rows20240201_df60a70e-e6c0-41b3-e053-2995a90af176.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 7 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Sosnowskis Magic Healing Multi actionCAMPHOR AND COLLOIDAL OATMEALHerstat (USA) Inc.38cd8f11-7264-a004-e063-6294a90a3a1b2026-07-03WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMPublix Super Markets, Inc.c94b5574-3fd7-48a8-94ef-db5d7184fa102026-07-02Warnings, Adverse reactionsExact identifier
application number: M016
Drs. Pharmacy Baby HealingZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY55a6981c-1b32-f448-e063-6294a90ac6d82026-07-02WarningsExact identifier
application number: M016
AVANCE ALOE INCONTINENCE CAREDIMETICONESMART CHOICE MEDICAL INC.558d239e-b0cf-c145-e063-6294a90a8a8b2026-07-01WarningsExact identifier
application number: M016
DIMETHICONE SKIN PROTECTANTDIMETHICONEVIVE HEALTH LLC5591a321-4831-1844-e063-6394a90a12d12026-07-01WarningsExact identifier
application number: M016
Drs. Pharmacy healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY55947cd9-ca25-0844-e063-6294a90a381f2026-07-01WarningsExact identifier
application number: M016
AVANCE ALOE INCONTINENCE CAREDIMETICONESMART CHOICE MEDICAL INC.55833e0f-d184-16a2-e063-6394a90acfd32026-06-30WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company55664a0f-7d46-f002-e063-6394a90a2dc72026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5566bce3-fc49-5ef4-e063-6294a90abc7a2026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet PlumCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5568ada5-3ae6-3366-e063-6294a90a71192026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted CoconutCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company55698d88-aae7-c46c-e063-6394a90ad0ac2026-06-29WarningsExact identifier
application number: M016
Earth Baby Diaper Rash CreamZINC OXIDEEarth Baby, Inc42c5cf9a-0a35-5681-e054-00144ff8d46c2026-06-28WarningsExact identifier
application number: M016
ORLASKIN HYDROGEL EYE MASKALLANTOINGuangzhou Yapheon Health Industry Co., Ltd.552d072b-396f-c88a-e063-6294a90aabcd2026-06-26WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP3c442890-733d-8175-e063-6294a90a8b1c2026-06-24WarningsExact identifier
application number: M016
MOROVANESTRIOLHONG KONG UNORDERED TRADING CO., LIMITED54fa4308-44a4-e9dd-e063-6394a90a0cd72026-06-24WarningsExact identifier
application number: M016
EELHOE Sleep Aid PatchGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.550b0494-ca6d-c897-e063-6394a90a87512026-06-24WarningsExact identifier
application number: M016
Hair Regrowth LiquidGLYCERINShantou Woodsleep Biotechnology Co., Ltd.54e662e7-9c63-ad6b-e063-6294a90a1b8d2026-06-23WarningsExact identifier
application number: M016
RoyceDerm Eczema Relief Body WashCOLLOIDAL OATMEAL 2%RoyceDerm LLC54e74eb4-1b42-a748-e063-6394a90aeb162026-06-23WarningsExact identifier
application number: M016
Comfort Shield BarrierDIMETHICONESage Products LLCcc08f571-84ae-4c2f-b09d-a83a8efc39f52026-06-23WarningsExact identifier
application number: M016
CLEAR ANTI ITCHPRAMOXINE HCL, ZINC ACETATE LOTIONH E B54f04056-d805-8c62-e063-6394a90ab7402026-06-23Warnings, Adverse reactionsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69435-1501-16943515010170.8 g in 1 TUBE, WITH APPLICATOR70.8 gHistorical
69435-1501-2694351501021 TUBE, WITH APPLICATOR in 1 BOX (69435-1501-2) / 70.8 g in 1 TUBE, WITH APPLICATOR (69435-1501-1) 2022-05-190000-00-00NoNoCurrent