FDA.reportPublic FDA data

Akin Diaper Rash

Product NDC
69822-003
11-digit product format
698220003
Labeler code
69822
Product ID
69822-003_0b57cdd0-d6fd-4e06-e063-6294a90a5af5
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Southern Sales & Service, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-25
Substance
ZINC OXIDE
Active strength
50 mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Akin Diaper Rash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
436525Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5515517-7977-48f9-aab6-cf0d2f2a04a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-003-06Akin Diaper Rash170 g in 1 TUBECREAM1703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-003AKIN DIAPER RASH (ZINC OXIDE) CREAM [SOUTHERN SALES & SERVICE, INC.]3Current NDC, Legacy NDC, 1 package rows20231201_f5515517-7977-48f9-aab6-cf0d2f2a04a0.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 24 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERADEX-EPETROLATUM AND LANOLINABBE Laboratories, Inc.00100102-c245-4b63-a4ff-794cacda6f172026-01-24WarningsExact identifier
application number: M016
HydrocortisoneDRS. HYDROCORTISONEOL PHARMA TECH,LLCb0eac8f3-bb80-6563-e053-2995a90a83c92026-01-22WarningsExact identifier
application number: M016
Eczema Reliegf Skin Protectant EQBCOLLOIDAL OATMEAL 2%Walmart37132a0d-37c5-4b21-9673-5f853b3a62482026-01-20WarningsExact identifier
application number: M016
Skin Relief CreamHYDROCORTISONESpa de Soleil0a90b77a-4be4-71c5-e063-6294a90a8e412026-01-20WarningsExact identifier
application number: M016
Cold Sore BandageCOLD SORE BANDAGEShenzhen Hengdasheng Technology Co., Ltd47f588a2-a69b-cffe-e063-6294a90a0ed42026-01-17WarningsExact identifier
application number: M016
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.48793a50-89a7-dba9-e063-6394a90a70562026-01-16WarningsExact identifier
application number: M016
HAND SANITIZERHAND SANITIZERGuangdong bangze medicine co., ltd40018618-8f95-f6db-e063-6394a90ac7dd2026-01-16WarningsExact identifier
application number: M016
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
application number: M016
WORKMANS FRIEND SUPERIOR BARRIER SKINDIMETHICONESolvChem, Inc.da12ac2c-1af9-47b1-aa5f-77acb48535ba2026-01-16WarningsExact identifier
application number: M016
Walgreens Vitamin A and D skin protectantLANOLIN, PETROLATUMWalgreen Company9aa6c7f2-0923-4d51-8b9b-63f9a724937a2026-01-15WarningsExact identifier
application number: M016
INCONTINENCE CARE WIPEDIMETHICONECardinal Health 200, Inc.1ac34c94-9e3b-45f2-ba19-a07dcd3941dd2026-01-15WarningsExact identifier
application number: M016
Alcohol Hand SanitizerALCOHOL HAND SANITIZERGuangdong bangze medicine co., ltd2e8b5afe-6ff8-3e9b-e063-6394a90ad7032026-01-14WarningsExact identifier
application number: M016
Alcohol SanitizerALCOHOL SANITIZER SPRAYGuangdong bangze medicine co., ltd2e9db49b-35ce-00d5-e063-6294a90acf352026-01-14WarningsExact identifier
application number: M016
GG XEROZINE 15SKIN PROTECTANTGERI-GENTLE CORPORATIONe6881c6d-f584-26d0-e053-2995a90a38732026-01-14WarningsExact identifier
application number: M016
Medpura Zinc Oxide 20%MEDPURA ZINC OXIDE 20%Akron Pharma Inc.3a63aaea-087e-4115-8478-64d416e6085f2026-01-14WarningsExact identifier
application number: M016
Walgreens Baby PetroleumPETROLATUMWalgreen Companye79f2bc2-e53b-4d01-9f9b-d9bd5c3b230d2026-01-14WarningsExact identifier
application number: M016
Walgreens Cocoa Butter JellyPETROLEUMWalgreens32b84286-471a-4d15-80fb-2f516dc1d6ea2026-01-14WarningsExact identifier
application number: M016
Hydrating Healing Skin ProtectantPETROLATUM OINTMENTCVS Pharmacyc129c2b0-10d5-4b5d-ac5c-2e2512e612792026-01-14WarningsExact identifier
application number: M016
Multi-Purpose Skin ProtectantA AND D OINTMENTCVS Pharmacy60bd0095-25d3-44af-9502-0c63b3d25e662026-01-14WarningsExact identifier
application number: M016
Kenkoderm Eczema Honey Intensive Soothing BalmKENKODERM ECZEMA HONEY INTENSIVE SOOTHING BALMGuangzhou Ariel Biotech Co., Ltd.48652b9c-4063-cc16-e063-6394a90a3b862026-01-14WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
436525zinc oxide 5 % Topical CreamPSNf5515517-7977-48f9-aab6-cf0d2f2a04a03
436525zinc oxide 50 MG/ML Topical CreamSCDf5515517-7977-48f9-aab6-cf0d2f2a04a03
436525zinc oxide 5 % Topical CreamSYf5515517-7977-48f9-aab6-cf0d2f2a04a03
436525ZNO 50 MG/ML Topical CreamSYf5515517-7977-48f9-aab6-cf0d2f2a04a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69822-003-0669822000306170 g in 1 TUBE (69822-003-06) 170 g2019-04-250000-00-00NoNoCurrent