Naturals by Safety 1st

Product NDC: 50428-3001
11-digit product format: 504283001
Labeler code: 50428
Product ID: 50428-3001_51c10961-bcf8-49d1-9b56-4825290b319e
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Dorel Juvenile Group
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-02-01
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 9 g/88mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50428-3001		I	Inactivated by FDA		2026-08-11
excluded package	package	50428-3001	50428-3001-8	I	Inactivated by FDA		2026-08-11

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 · 44 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50428-3001-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50428-3001-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50428-3001-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50428-3001-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50428-3001-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50428-3001-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50428-3001-8	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50428-3001-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50428-3001-8	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50428-3001-8	`ad56d346431e…`	`cc804d4bbf1e…`
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	50428-3001-8	`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	50428-3001-8	`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	50428-3001-8	`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	50428-3001-8	`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	50428-3001-8	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50428-3001-8	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50428-3001-8	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50428-3001-8	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50428-3001-8	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	50428-3001-8	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	50428-3001-8	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50428-3001-8	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50428-3001-8	2019-11-27	C162847	48780-1	9855d018-d4cc-cd31-e053-dbdaa90ab51a	Naturals™ by Safety 1st® Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50428-3001-7	Naturals by Safety 1st	88 mL in 1 TUBE	OINTMENT	88		2
50428-3001-8	Naturals by Safety 1st	6 in 1 CARTON	OINTMENT	6		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
CANOLA OIL	INACTIVE INGREDIENT	331KBJ17RK	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
CETEARYL GLUCOSIDE	INACTIVE INGREDIENT	09FUA47KNA	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
LONICERA CAPRIFOLIUM FLOWER	INACTIVE INGREDIENT	5N1WD9784U	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
LONICERA JAPONICA FLOWER	INACTIVE INGREDIENT	4465L2WS4Y	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50428-3001	NATURALS BY SAFETY 1ST (ZINC OXIDE) OINTMENT [DOREL JUVENILE GROUP]	2	Legacy NDC, 2 package rows	20121114_183c6b92-33dd-4b45-8681-0e7af70015c0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199099	zinc oxide 10 % Topical Ointment	PSN	183c6b92-33dd-4b45-8681-0e7af70015c0	2
199099	zinc oxide 0.1 MG/MG Topical Ointment	SCD	183c6b92-33dd-4b45-8681-0e7af70015c0	2
199099	zinc oxide 10 % Topical Ointment	SY	183c6b92-33dd-4b45-8681-0e7af70015c0	2
199099	ZNO 0.1 MG/MG Topical Ointment	SY	183c6b92-33dd-4b45-8681-0e7af70015c0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50428-3001-7	50428300107	88 mL in 1 TUBE	88 ml	Historical
50428-3001-8	50428300108	6 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naturals™ by Safety 1st® Diaper Rash Cream	Dorel Juvenile Group	2012-11-09	HUMAN OTC DRUG LABEL	2