FDA.reportPublic FDA data

Intertrigo Relief Cream

Product NDC
84983-041
11-digit product format
849830041
Labeler code
84983
Product ID
84983-041_587220c9-0aea-3438-e063-6394a90a0a86
Type
HUMAN OTC DRUG
Nonproprietary name
GLYCERIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Shantou South Moon Biotechnology Co., Ltd.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-07
Substance
CAMELLIA SINENSIS LEAF OIL; HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER; ZINC OXIDE; UNDECYLENIC ACID
Active strength
.003; .003; 4.5; 3 mg/30mg; mg/30mg; mg/30mg; mg/30mg
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
Intertrigo Relief Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMELLIA SINENSIS LEAF OIL.003 mg/30mg
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER.003 mg/30mg
ZINC OXIDE4.5 mg/30mg
UNDECYLENIC ACID3 mg/30mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VC855RRT77Internal UNII lookup
8FP93ED6H2Internal UNII lookup
SOI2LOH54ZInternal UNII lookup
K3D86KJ24NInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
587220c9-0ae9-3438-e063-6394a90a0a86Available on FDA.report

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 35 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Witch HazelWITCH HAZELMeijer Distribution Inc03f23b04-e7f7-49b7-e063-6294a90ad58a2025-10-31WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC1852246a-6a1c-49ab-e063-6294a90a90482025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b531c1-9ab0-5ff1-e063-6394a90a29752025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b650bd-18fe-8696-e063-6394a90aa9a22025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b5f354-3379-3d9f-e063-6294a90ae8172025-10-30WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.59d90652-a471-4f77-a3d5-88aad9dc9e132025-10-30WarningsExact identifier
application number: M016
CVS Cools Itch FastHYDROCORTISONECVS Pharmacy, Inc.8a4544df-bbba-47d2-ada0-352757abc91f2025-10-29WarningsExact identifier
application number: M016
Winco Maximum Strength HydrocortisoneHYDROCORTISONEWINCO FOODS, LLCb1812ea3-78cc-607a-e053-2a95a90a0a102025-10-29WarningsExact identifier
application number: M016
Good Neighbor Pharmacy Skin ProtectantZINC OXIDEAMERISOURCE BERGENc28e63f1-34be-9206-e053-2995a90accf62025-10-29WarningsExact identifier
application number: M016
Remedy NutrashieldDIMETHICONEMedline Industries, LPed8a08a7-594c-46e2-b70f-b75b2960141f2025-10-28WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)MY IMPORTS USA LLC421da126-a1c4-54d7-e063-6394a90ac4012025-10-27WarningsExact identifier
application number: M016
GeriGardZINC OXIDEGeri-Gentle Corporation05b67830-adc8-46b1-b0a0-a6cd2875e80c2025-10-27WarningsExact identifier
application number: M016
Boudreauxs Butt BarrierDIMETHICONEC.B. Fleet Company, Inc.06a5af4d-40dd-42a4-8368-4d6a772d1b3a2025-10-27WarningsExact identifier
application number: M016
Boudreauxs Baby Shower BundleZINC OXIDEC.B. Fleet Company, Inc.a289ed3c-3c7a-4eda-bf5e-139203d2e17e2025-10-27WarningsExact identifier
application number: M016
WinCo Original Strength Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATEWinCo Foods, LLCae74e163-ba1a-4d1e-aaeb-9976bd2026742025-10-24WarningsExact identifier
application number: M016
Maximum Strength Moisture BarrierPETROLATUM AND ZINC OXIDEDerma Sciences Canada Inc.41ee91c0-d196-cc0f-e063-6394a90a7b972025-10-24WarningsExact identifier
application number: M016
TenderphorSKIN PROTECTANTGERI-GENTLE CORPORATIONe6763da3-cbd1-7a86-e053-2995a90a26c12025-10-23WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.262278f6-7e4c-44ee-b40d-39662a239d732025-10-23WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b8cb00-a04e-52f0-e063-6294a90aabf72025-10-22WarningsExact identifier
application number: M016
WinCo Foods Hydrocortisone Cream Intensive HealingHYDROCORTISONEWINCO FOODS, LLCac4e0e24-9295-b83b-e053-2995a90a996f2025-10-22WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84983-041-018498300410130 mg in 1 TUBE (84983-041-01) 30 mg2026-08-07NoNoCurrent