VITACILINA Bebe Diaper Rash

Product NDC: 54312-525
11-digit product format: 543120525
Labeler code: 54312
Product ID: 54312-525_471d2450-a938-69cf-e063-6294a90ac7c1
Type: HUMAN OTC DRUG
Nonproprietary name: ALLANTOIN, ZINC OXIDE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Compania Internacional de Comercio, S.A.P.I de C.V.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-09-30
Substance: ALLANTOIN; ZINC OXIDE
Active strength: 10; 250 mg/g; mg/g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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: VITACILINA Bebe Diaper Rash
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALLANTOIN	10 mg/g
ZINC OXIDE	250 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
344S277G0Z	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1441179	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
39726b59-bd85-4541-80e5-4f2919842dca	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54312-525-16	VITACILINA Bebe Diaper Rash	1 in 1 PACKAGE	OINTMENT	1		20
54312-525-16	VITACILINA Bebe Diaper Rash	50 g in 1 TUBE	OINTMENT	50		20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLANTOIN	ACTIVE INGREDIENT	344S277G0Z	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5
ALLANTOIN	ACTIVE MOIETY	344S277G0Z	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5
VITAMIN A	INACTIVE INGREDIENT	81G40H8B0T	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5
VITAMIN D	INACTIVE INGREDIENT	9VU1KI44GP	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54312-525	VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]	16	Current NDC, Legacy NDC, 2 package rows	20241031_39726b59-bd85-4541-80e5-4f2919842dca.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 7 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sosnowskis Magic Healing Multi action	CAMPHOR AND COLLOIDAL OATMEAL	Herstat (USA) Inc.	38cd8f11-7264-a004-e063-6294a90a3a1b	2026-07-03	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Publix Super Markets, Inc.	c94b5574-3fd7-48a8-94ef-db5d7184fa10	2026-07-02	Warnings, Adverse reactions	Exact identifier application number: M016
Drs. Pharmacy Baby Healing	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	55a6981c-1b32-f448-e063-6294a90ac6d8	2026-07-02	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	558d239e-b0cf-c145-e063-6294a90a8a8b	2026-07-01	Warnings	Exact identifier application number: M016
DIMETHICONE SKIN PROTECTANT	DIMETHICONE	VIVE HEALTH LLC	5591a321-4831-1844-e063-6394a90a12d1	2026-07-01	Warnings	Exact identifier application number: M016
Drs. Pharmacy healing	PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	55947cd9-ca25-0844-e063-6294a90a381f	2026-07-01	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	55833e0f-d184-16a2-e063-6394a90acfd3	2026-06-30	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55664a0f-7d46-f002-e063-6394a90a2dc7	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5566bce3-fc49-5ef4-e063-6294a90abc7a	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet Plum	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5568ada5-3ae6-3366-e063-6294a90a7119	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted Coconut	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55698d88-aae7-c46c-e063-6394a90ad0ac	2026-06-29	Warnings	Exact identifier application number: M016
Earth Baby Diaper Rash Cream	ZINC OXIDE	Earth Baby, Inc	42c5cf9a-0a35-5681-e054-00144ff8d46c	2026-06-28	Warnings	Exact identifier application number: M016
ORLASKIN HYDROGEL EYE MASK	ALLANTOIN	Guangzhou Yapheon Health Industry Co., Ltd.	552d072b-396f-c88a-e063-6294a90aabcd	2026-06-26	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM	Medline Industries, LP	3c442890-733d-8175-e063-6294a90a8b1c	2026-06-24	Warnings	Exact identifier application number: M016
MOROVAN	ESTRIOL	HONG KONG UNORDERED TRADING CO., LIMITED	54fa4308-44a4-e9dd-e063-6394a90a0cd7	2026-06-24	Warnings	Exact identifier application number: M016
EELHOE Sleep Aid Patch	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	550b0494-ca6d-c897-e063-6394a90a8751	2026-06-24	Warnings	Exact identifier application number: M016
Hair Regrowth Liquid	GLYCERIN	Shantou Woodsleep Biotechnology Co., Ltd.	54e662e7-9c63-ad6b-e063-6294a90a1b8d	2026-06-23	Warnings	Exact identifier application number: M016
RoyceDerm Eczema Relief Body Wash	COLLOIDAL OATMEAL 2%	RoyceDerm LLC	54e74eb4-1b42-a748-e063-6394a90aeb16	2026-06-23	Warnings	Exact identifier application number: M016
Comfort Shield Barrier	DIMETHICONE	Sage Products LLC	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	2026-06-23	Warnings	Exact identifier application number: M016
CLEAR ANTI ITCH	PRAMOXINE HCL, ZINC ACETATE LOTION	H E B	54f04056-d805-8c62-e063-6394a90ab740	2026-06-23	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
344S277G0Z	ALLANTOIN	97-59-6	ALLANTOIN
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1441179	allantoin 1 % / zinc oxide 25 % Topical Ointment	PSN	39726b59-bd85-4541-80e5-4f2919842dca	20
1441179	allantoin 0.01 MG/MG / zinc oxide 0.25 MG/MG Topical Ointment	SCD	39726b59-bd85-4541-80e5-4f2919842dca	20
1441179	Allantoin 0.01 MG/MG / ZNO 0.25 MG/MG Topical Ointment	SY	39726b59-bd85-4541-80e5-4f2919842dca	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54312-525-16	54312052516	1 TUBE in 1 PACKAGE (54312-525-16) / 50 g in 1 TUBE	1 tube	2013-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VITACILINA Bebe Diaper Rash Ointment	Compania Internacional de Comercio, S.A.P.I de C.V.	2025-12-29	HUMAN OTC DRUG LABEL	20