Gentle STEPS vitamins A and D Diaper Rash and Skin Protectant

Product NDC: 55910-805
11-digit product format: 559100805
Labeler code: 55910
Product ID: 55910-805_1d925e44-e301-4410-ade1-e45edb594d8d
Type: HUMAN OTC DRUG
Nonproprietary name: Lanolin, Petrolatum
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Old East Main CO.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-10-06
Substance: LANOLIN; PETROLATUM
Active strength: 15.5; 53.4 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55910-805-72	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55910-805-72	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55910-805-72	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55910-805-72	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55910-805-72	`1332a3947898…`	`d4bfe170f9cd…`

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: Gentle STEPS vitamins A and D Diaper Rash and Skin Protectant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LANOLIN	15.5 g/100g
PETROLATUM	53.4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7EV65EAW6H	Internal UNII lookup
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
664981	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
1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55910-805-72	2024-10-14	C162847	48780-1	f386c64a-09e2-0266-e053-dadaa90a7c1a	Gentle STEPS ® vitamins A & D Diaper Rash Ointment & Skin Protectant
55910-805-72	2023-01-30	C162847	48780-1	f386c64a-09e2-0266-e053-dadaa90a7c1a	Gentle STEPS ® vitamins A & D Diaper Rash Ointment & Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55910-805-72	Gentle STEPS vitamins A and D Diaper Rash and Skin Protectant	1 in 1 BOX	OINTMENT	1		3
55910-805-72	Gentle STEPS vitamins A and D Diaper Rash and Skin Protectant	113 g in 1 TUBE	OINTMENT	113		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-805	GENTLE STEPS VITAMINS A AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN, PETROLATUM) OINTMENT [OLD EAST MAIN CO.]	3	Current NDC, Legacy NDC, 2 package rows	20241016_1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d.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 68 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Vital Line	HYDROLYZED COLLAGEN	ANUBIS COSMETICS SL	f564bbf0-3b5c-4a81-e053-2a95a90a7ea6	2023-08-29	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), PETROLATUM	Carma Laboratories, Inc.	5378d653-702d-405c-a067-882554aaf93a	2023-08-21	Warnings	Exact identifier application number: M016
Quality Choice Anti-itch Medicated	CALAMINE AND PRAMOXINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5e07f26f-cfb6-57f9-e053-2991aa0a2008	2023-08-02	Warnings	Exact identifier application number: M016
Barrier Balm	BARRIER BALM	Autumn Harp, Inc.	01df9746-991b-4363-e063-6294a90aaac6	2023-08-01	Warnings	Exact identifier application number: M016
Barrier Cream	ZINC OXIDE	Avasol LLC	bc6a2736-faa6-46d3-af9b-a70f0762e9ce	2023-05-15	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	bec2f702-5ff5-ea66-e053-2a95a90ad1ec	2023-01-01	Warnings	Exact identifier application number: M016
Badger After-BUG Balm	COLLOIDAL OATMEAL	W.S. Badger Company, Inc.	a623da47-cef2-146f-e053-2a95a90afe3a	2021-11-17	Warnings	Exact identifier application number: M016
Derma-e Eczema Relief	OATMEAL	Topiderm, Inc	e1797f81-af4b-49e1-9906-dbfd904a282b	2020-08-19	Warnings	Exact identifier application number: M016
Resurfix Plus	PETROLATUM	Topiderm, Inc.	f100f43d-6ace-4c3a-9c85-640c0ab2e360	2019-11-19	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7EV65EAW6H	LANOLIN	8006-54-0	LANOLIN
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
664981	lanolin 15.5 % / petrolatum 53.4 % Topical Ointment	PSN	1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d	3
664981	lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical Ointment	SCD	1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d	3
664981	lanolin 15.5 % / petrolatum 53.4 % Topical Ointment	SY	1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d	3
664981	lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical Ointment	SY	1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-805-72	55910080572	1 TUBE in 1 BOX (55910-805-72) / 113 g in 1 TUBE	1 tube	2021-10-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gentle STEPS ® vitamins A & D Diaper Rash Ointment & Skin Protectant	Old East Main CO. \| Ashtel Studios Inc.	2024-10-11	HUMAN OTC DRUG LABEL	3