EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE

Product NDC: 67938-1149
11-digit product format: 679381149
Labeler code: 67938
Product ID: 67938-1149_9f78a938-c8af-460d-ae67-e75a5b1f6ad6
Type: HUMAN OTC DRUG
Nonproprietary name: PETROLATUM
Dosage form: CREAM
Route: TOPICAL
Labeler: Elizabeth Arden, Inc
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-07-07
Marketing end: 0000-00-00
Substance: PETROLATUM
Active strength: 28 g/50g
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67938-1149		I	Inactivated by FDA	2026-10-05
excluded package	package	67938-1149	67938-1149-1	I	Inactivated by FDA	2026-10-05
excluded package	package	67938-1149	67938-1149-3	I	Inactivated by FDA	2026-10-05
excluded package	package	67938-1149	67938-1149-4	I	Inactivated by FDA	2026-10-05

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 2 · 88 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	67938-1149-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67938-1149-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67938-1149-4	`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	67938-1149-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67938-1149-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67938-1149-4	`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	67938-1149-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67938-1149-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67938-1149-4	`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	67938-1149-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67938-1149-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67938-1149-4	`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	67938-1149-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67938-1149-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67938-1149-4	`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	67938-1149-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67938-1149-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67938-1149-4	`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	67938-1149-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67938-1149-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67938-1149-4	`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	67938-1149-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67938-1149-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67938-1149-4	`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	67938-1149-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67938-1149-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67938-1149-4	`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	67938-1149-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67938-1149-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67938-1149-4	`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	67938-1149-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67938-1149-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67938-1149-4	`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	67938-1149-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67938-1149-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67938-1149-4	`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	67938-1149-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67938-1149-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67938-1149-4	`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	67938-1149-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67938-1149-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67938-1149-4	`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	67938-1149-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67938-1149-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67938-1149-4	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67938-1149-1	2020-01-31	C162847	48780-1	9d75b9d0-3070-f424-e053-dadaa90a57ce	BC1149
67938-1149-3	2020-01-31	C162847	48780-1	9d75b9d0-3070-f424-e053-dadaa90a57ce	BC1149
67938-1149-4	2020-01-31	C162847	48780-1	9d75b9d0-3070-f424-e053-dadaa90a57ce	BC1149

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67938-1149-1	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE	1 in 1 BOX	CREAM	1	1
67938-1149-2	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE	50 g in 1 TUBE	CREAM	50	1
67938-1149-3	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE	2 g in 1 PACKET	CREAM	2	1
67938-1149-4	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE	1 in 1 BOX	CREAM	1	1
67938-1149-5	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE	28 g in 1 TUBE	CREAM	28	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE (PETROLATUM) CREAM [ELIZABETH ARDEN, INC]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE (PETROLATUM) CREAM [ELIZABETH ARDEN, INC]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE (PETROLATUM) CREAM [ELIZABETH ARDEN, INC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE (PETROLATUM) CREAM [ELIZABETH ARDEN, INC]	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE (PETROLATUM) CREAM [ELIZABETH ARDEN, INC]	1
VANILLIN	INACTIVE INGREDIENT	CHI530446X	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE (PETROLATUM) CREAM [ELIZABETH ARDEN, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67938-1149	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE (PETROLATUM) CREAM [ELIZABETH ARDEN, INC]	1	Legacy NDC, 5 package rows	20111011_afa8c6d1-2a26-4506-8f3e-35a2a22dcfcc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1189921	petrolatum 56.8 % Topical Cream	PSN	afa8c6d1-2a26-4506-8f3e-35a2a22dcfcc	1
1189921	petrolatum 568 MG/ML Topical Cream	SCD	afa8c6d1-2a26-4506-8f3e-35a2a22dcfcc	1
1189921	petrolatum 56.8 % Topical Cream	SY	afa8c6d1-2a26-4506-8f3e-35a2a22dcfcc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67938-1149-1	67938114901	1 in 1 BOX		Historical
67938-1149-2	67938114902	50 g in 1 TUBE	50 g	Historical
67938-1149-3	67938114903	2 g in 1 PACKET	2 g	Historical
67938-1149-4	67938114904	1 in 1 BOX		Historical
67938-1149-5	67938114905	28 g in 1 TUBE	28 g	Historical