FDA.reportPublic FDA data

Bed Sore and Wound Healing Cream

Product NDC
85384-0011
11-digit product format
853840011
Labeler code
85384
Product ID
85384-0011_56777d68-b6cb-43fa-bca3-7ab7998b15a7
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
CREAM
Route
TOPICAL
Labeler
TAGRID LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-02
Substance
ALLANTOIN
Active strength
5 mg/g
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
Bed Sore and Wound Healing Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN5 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85384-0011-1Bed Sore and Wound Healing Cream30 g in 1 TUBECREAM302

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 31 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediadermics eczema 3COLLOIDAL OATMEAL, DIMETHICONERenu Laboratories, LLCaf861f0b-4387-6861-e053-2995a90a8bfa2025-12-02WarningsExact identifier
application number: M016
Flexitol Face and Eyelid EczemaOATMEALLaCorium Health USA Inc.f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee652025-12-02WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 41%Twin Med LLC3d36e664-ac10-72eb-e063-6294a90a49c42025-12-01WarningsExact identifier
application number: M016
ProCure Vitamin A and DWHITE PETROLATUM 93.4%Twin Med LLC3d385a07-2a12-fce7-e063-6294a90a32d62025-12-01WarningsExact identifier
application number: M016
ESTRIOLESTRIOLShenzhen Mengyue Technology Co., Ltd.44de9eb4-080e-bfbc-e063-6394a90ac0ea2025-12-01WarningsExact identifier
application number: M016
CareALL Creamy Petroleum JellyPETROLATUMNew World Imports, Ince13fea4e-bd6d-425a-aa7e-1d41dc36bf002025-12-01WarningsExact identifier
application number: M016
CareALL Creamy Cocoa Butter Petroleum JellyPETROLATUMNew World Imports, Inc9358b8ef-df14-45fc-9bfd-9052577a1f882025-12-01WarningsExact identifier
application number: M016
CAREALL Zinc OxideZINC OXIDENew World Imports Incaa9ae4d1-4229-4894-9eaf-8588b28674722025-12-01WarningsExact identifier
application number: M016
CAREALL PetroleumPETROLATUMNew World Imports, Inc47e999de-08bd-4121-b6d0-270cc603b56d2025-12-01WarningsExact identifier
application number: M016
HOEGOA Growth Hair SerumGLYCERINShantou Oralhoe Biotechnology Co., Ltd.44b6609f-c58b-b6ac-e063-6394a90a749b2025-11-29WarningsExact identifier
application number: M016
OUHOE Micro Darts Tag gone PatchGLYCERINShantou Ouhoe Technology Co., Ltd.33ce447c-facd-35fb-e063-6394a90a1ead2025-11-27WarningsExact identifier
application number: M016
OUHOE Herbal Hair OilGLYCERINShantou Ouhoe Technology Co., Ltd.30c3df30-e0c6-4efa-e063-6294a90ac40a2025-11-27WarningsExact identifier
application number: M016
OUHOE Aloe Soothing Sun CreamGLYCERINShantou Ouhoe Technology Co., Ltd.326781e0-55dc-80fc-e063-6394a90a09aa2025-11-27WarningsExact identifier
application number: M016
OUHOE Ultra Anti-Acne Control GelGLYCERINShantou Ouhoe Technology Co., Ltd.3bd1b734-76b0-5264-e063-6294a90a32d02025-11-27WarningsExact identifier
application number: M016
OUHOE Lipoma CreamGLYCERINShantou Ouhoe Technology Co., Ltd.3cb4aed1-3b13-a62a-e063-6294a90a6c392025-11-27WarningsExact identifier
application number: M016
OUHOE Para CrescimentoGLYCERINShantou Ouhoe Technology Co., Ltd.42fbfcac-29ab-51f7-e063-6394a90a626f2025-11-27WarningsExact identifier
application number: M016
OUHOE Biotin With Hydrolyzed CollagenGLYCERINShantou Ouhoe Technology Co., Ltd.43138915-5fe1-6e32-e063-6294a90abefa2025-11-27WarningsExact identifier
application number: M016
EELHOE Pain Relief PatchGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3f835843-eb04-6273-e063-6294a90ab2f02025-11-27WarningsExact identifier
application number: M016
EELHOE Skin Tag RemoverGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.32922508-74ae-8347-e063-6294a90a61542025-11-27WarningsExact identifier
application number: M016
EELHOE Bodyacne Removal CleanserGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3bbebf1d-2e22-1427-e063-6294a90a79992025-11-27WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
241509allantoin 0.5 % Topical CreamPSN389e27c8-f16a-4028-92b4-813a26114d152
241509allantoin 5 MG/ML Topical CreamSCD389e27c8-f16a-4028-92b4-813a26114d152
241509allantoin 0.5 % Topical CreamSY389e27c8-f16a-4028-92b4-813a26114d152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85384-0011-18538400110130 g in 1 TUBE (85384-0011-1) 30 g2025-06-02NoNoCurrent