Babyganics Soothing Itch

Product NDC
59062-3301
11-digit product format
590623301
Labeler code
59062
Product ID
59062-3301_276ffcf7-af12-4eec-87c7-e4a4aa7152b4
Type
HUMAN OTC DRUG
Nonproprietary name
OATMEAL
Dosage form
STICK
Route
TOPICAL
Labeler
KAS Direct, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
OATMEAL
Active strength
100 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
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
Babyganics Soothing Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8PI54V663YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1745093Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c2806fb-5af4-4532-b31a-be77bb23b277Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-3301-1Babyganics Soothing Itch1 in 1 CARTONSTICK11
59062-3301-1Babyganics Soothing Itch18 g in 1 APPLICATORSTICK181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-3301BABYGANICS SOOTHING ITCH (OATMEAL) STICK [KAS DIRECT, LLC]1Current NDC, 2 package rows20240901_5c2806fb-5af4-4532-b31a-be77bb23b277.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 62 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil HealingPETROLATUMGalderma Laboratories, L.P.e996db17-bd4d-4b06-bb9a-983dbdec80222024-03-13WarningsExact identifier
application number: M016
Diaper Rash Cream 2ozZINC OXIDERejoice International Corp.130a06a7-3360-afed-e063-6294a90ac19f2024-03-06WarningsExact identifier
application number: M016
mama bear DIAPER RASH Skin ProtectantLANOLIN AND PETROLATUMAMAZON.COM SERVICES LLCcda9ca47-b668-4a65-908d-80b9a6515bd72024-03-06WarningsExact identifier
application number: M016
Dermachange ScarALLANTOINPrivate Label Beauty and Wellness12eed473-10d6-49c8-e063-6394a90afb632024-03-05WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum Jelly Cocoa Butter EnrichedPETROLEUMRejoice International580d76ee-ea89-426e-bd25-7a58481e97952024-02-28WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum Jelly Vitamin E enrichedPETROLATUMRejoice International2c382a50-93d2-4d28-b7a4-1702b20b71392024-02-28WarningsExact identifier
application number: M016
XtraCare Foaming Facial CleanserTRICLOSANRejoice International313fcd4a-8641-417e-bf0b-02359ad815fe2024-02-28WarningsExact identifier
application number: M016
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International5ae6d5d4-caff-4360-a0e7-7c8d7a9b59072024-02-28WarningsExact identifier
application number: M016
XtraCare with cooling action Oatmeal Skin Relief CalminDIMETHICONERejoice International29abd476-c32d-49f0-b283-30f4ba570ab42024-02-28WarningsExact identifier
application number: M016
MAX BARRIER Skin ProtectantZINC OXIDEGL HEALTH, INC.5eec834d-d8f3-49e3-b230-f8cf88b795e62024-02-26WarningsExact identifier
application number: M016
Rugby Petrolatum Hydrating Skin ProtectantPETROLATUMRugby Laboratoriesad63e345-1fe8-4f9a-a32e-8dfcde31bedc2024-02-12WarningsExact identifier
application number: M016
A and DPETROLATUMSafetec of America, Inc.b9afda3a-9e1d-46c1-b7aa-c3143caf709e2024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Mint BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc86fc9f3c-e35f-4988-bf19-64d9c6c85ee92024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Berry BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc827365b3-b3a5-4472-9add-f822362c47312024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Lip BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc8b4160ed-8889-4e3a-947f-a56c3324dbbe2024-02-09WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP101b9933-c2b8-0fdd-e063-6294a90a306a2024-01-29WarningsExact identifier
application number: M016
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc2024-01-29WarningsExact identifier
application number: M016
Cetaphil Baby HealingPETROLATUMGalderma Laboratories, L.P.5140754e-5db0-470f-adfd-de02b184880b2024-01-29WarningsExact identifier
application number: M016
CHAPSTICK CLASSIC MEDICATEDCAMPHOR, MENTHOL, PETROLATUMHaleon US Holdings LLCb4259621-ff41-46cc-a658-b57bff3c15252024-01-23WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USAfcef17f1-84e7-a288-e053-6294a90a064b2024-01-19WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745093colloidal oatmeal 10 % Topical OintmentPSN5c2806fb-5af4-4532-b31a-be77bb23b2771
1745093colloidal oatmeal 0.1 MG/MG Topical OintmentSCD5c2806fb-5af4-4532-b31a-be77bb23b2771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59062-3301-1590623301011 APPLICATOR in 1 CARTON (59062-3301-1) / 18 g in 1 APPLICATOR1 applicator2024-09-01NoNoCurrent