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
Ingredient	Strength
ALLANTOIN	5 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85384-0011-1	Bed Sore and Wound Healing Cream	30 g in 1 TUBE	CREAM	30		2

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 65 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GNP Witch Hazel	WITCH HAZEL	Amerisource Bergen	45ac839d-215d-4c5f-8ae5-5e111d170061	2023-12-14	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant	GLYCERIN	L'Oreal USA Products Inc	32eaaaab-41bd-4efe-a71d-92e3a702c1e5	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief	OATMEAL	COSMETIQUE ACTIVE PRODUCTION	e555de17-9b42-4125-a17b-467bc1d179d7	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief	OATMEAL	L'Oreal USA Products Inc	f7b71606-0044-4729-82e8-4514331806a0	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5	GLYCERIN	Cosmetique Active Production	01c8a0d5-bcd1-4639-be45-530a226401f0	2023-12-11	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	0bc6812a-5c2a-7bb9-e063-6294a90a36e3	2023-12-05	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	34fae56e-367d-4659-af2d-1c9ddaf1639c	2023-12-05	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	Rejoice International Corp.	0ba98cdf-489e-dc2a-e063-6294a90adb38	2023-12-04	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	China Ningbo Shangge Cosmetics Technology Corp.	0baa8a14-8655-d77c-e063-6294a90ab8aa	2023-12-04	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy	OATMEAL	THERAPLEX, LLC	86472a3d-7138-4141-8422-ab20c17a46e0	2023-12-04	Warnings	Exact identifier application number: M016
SOOTHE Moisturizing Rescue Cream	OATMEAL	Rodan & Fields	91163267-c2aa-47b3-b290-d1605536d806	2023-12-04	Warnings	Exact identifier application number: M016
Manzatin-E Diaper Rash Skin Protectant	ZINC OXIDE	Laboratorios Zepol S.A.	cafd084f-8493-4d6e-b256-2d4b4282f866	2023-12-01	Warnings	Exact identifier application number: M016
Manzatin Diaper Rash Skin Protectant	ZINC OXIDE	Laboratorios Zepol S.A.	5c1618a4-ca08-4814-a556-74e79db618b9	2023-12-01	Warnings	Exact identifier application number: M016
Petrolatum Jelly	PETROLATUM	NEW PRIDE CORP	f6634410-fa1f-7987-e053-2995a90abb06	2023-12-01	Warnings	Exact identifier application number: M016
Cetaphil Cracked Skin Repair Balm	DIMETHICONE	Galderma Laboratories, L.P.	5efb3ef0-6ee9-4ef8-b81e-90bd1825c956	2023-11-30	Warnings	Exact identifier application number: M016
Cetaphil Cracked Skin Repair	DIMETHICONE	Galderma Laboratories, L.P.	27d74e0f-8359-4c59-bf7f-acade7f4545c	2023-11-30	Warnings	Exact identifier application number: M016
Sheffield Advanced Scar Gel	ADVANCED SCAR GEL	Sheffield Pharmaceuticals LLC	ab78b946-81ed-442c-a167-26c26c7fe8a1	2023-11-30	Warnings	Exact identifier application number: M016
Akin Diaper Rash	ZINC OXIDE	Southern Sales & Service, Inc.	f5515517-7977-48f9-aab6-cf0d2f2a04a0	2023-11-29	Warnings	Exact identifier application number: M016
Dr. Sheffield Diaper Rash	ZINC OXIDE	Sheffield Pharmaceuticals LLC	cac77320-b5cf-4edf-9693-ebabfb61390c	2023-11-28	Warnings	Exact identifier application number: M016
Sheffield Zinc Oxide	ZINC OXIDE	Sheffield Pharmaceuticals LLC	60b54c04-4387-4954-951d-165809947310	2023-11-28	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
344S277G0Z	ALLANTOIN	97-59-6	ALLANTOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
241509	allantoin 0.5 % Topical Cream	PSN	389e27c8-f16a-4028-92b4-813a26114d15	2
241509	allantoin 5 MG/ML Topical Cream	SCD	389e27c8-f16a-4028-92b4-813a26114d15	2
241509	allantoin 0.5 % Topical Cream	SY	389e27c8-f16a-4028-92b4-813a26114d15	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85384-0011-1	85384001101	30 g in 1 TUBE (85384-0011-1)	30 g	2025-06-02	No	No	Current