Theraplex

Product NDC: 62917-065
11-digit product format: 629170065
Labeler code: 62917
Product ID: 62917-065_91199a78-e92e-487e-8417-f0c5ee60d6d2
Type: HUMAN OTC DRUG
Nonproprietary name: PETROLATUM
Dosage form: CREAM
Route: TOPICAL
Labeler: The Theraplex Company, LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-10-23
Marketing end: 0000-00-00
Substance: PETROLATUM
Active strength: 65 g/100g
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	62917-065		I	Inactivated by FDA	2026-10-05
excluded product	product	62917-065		I	Inactivated by FDA	2026-10-05
excluded product	product	62917-065		I	Inactivated by FDA	2026-10-05
excluded package	package	62917-065	62917-065-08	I	Inactivated by FDA	2026-10-05
excluded package	package	62917-065	62917-065-14	I	Inactivated by FDA	2026-10-05
excluded package	package	62917-065	62917-065-02	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 · 114 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
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	62917-065-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62917-065-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62917-065-14	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
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	62917-065-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62917-065-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62917-065-14	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
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	62917-065-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62917-065-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62917-065-14	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
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	62917-065-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62917-065-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62917-065-14	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
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	62917-065-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62917-065-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62917-065-14	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
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	62917-065-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62917-065-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62917-065-14	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
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	62917-065-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62917-065-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62917-065-14	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
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	62917-065-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62917-065-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62917-065-14	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
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	62917-065-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62917-065-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62917-065-14	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
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	62917-065-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62917-065-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62917-065-14	`ad56d346431e…`	`cc804d4bbf1e…`

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
62917-065-02	2021-07-23	C162847	48780-1	c7ccaba7-1932-fd44-e053-dadaa90aa01b	Theraplex Healing Emollient
62917-065-08	2021-07-23	C162847	48780-1	c7ccaba7-15c0-fd44-e053-dadaa90aa01b	theraplex HEALING EMOLLIENT
62917-065-14	2021-07-23	C162847	48780-1	c7ccaba7-15bd-fd44-e053-dadaa90aa01b	Theraplex Healing Emollient

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62917-065-02	TheraplexHealing Emollient	56.6 g in 1 JAR	CREAM	56.6	1
62917-065-08	TheraplexHEALING EMOLLIENT	226.7 g in 1 JAR	CREAM	226.7	1
62917-065-14	TheraplexHealing Emollient	397 g in 1 JAR	CREAM	397	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	THERAPLEX HEALING EMOLLIENT (PETROLATUM) CREAM [THE THERAPLEX COMPANY, LLC]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	THERAPLEX HEALING EMOLLIENT (PETROLATUM) CREAM [THE THERAPLEX COMPANY, LLC]	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	THERAPLEX HEALING EMOLLIENT (PETROLATUM) CREAM [THE THERAPLEX COMPANY, LLC]	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	THERAPLEX HEALING EMOLLIENT (PETROLATUM) CREAM [THE THERAPLEX COMPANY, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62917-065	THERAPLEX HEALING EMOLLIENT (PETROLATUM) CREAM [THE THERAPLEX COMPANY, LLC]	1	Legacy NDC, 1 package rows	20151027_e76e2f90-8c10-4354-8dfe-b4358018645c.zip
62917-065	THERAPLEX HEALING EMOLLIENT (PETROLATUM) CREAM [THE THERAPLEX COMPANY, LLC]	1	Legacy NDC, 1 package rows	20170501_1af2e6c9-aa62-43a3-9eaf-342fe1bdd598.zip
62917-065	THERAPLEX HEALING EMOLLIENT (PETROLATUM) CREAM [THE THERAPLEX COMPANY, LLC]	1	Legacy NDC, 1 package rows	20170501_b4e90178-b6c6-49c0-b0b6-b4e73eca2094.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
1716270	petrolatum 65 % Topical Cream	PSN	1af2e6c9-aa62-43a3-9eaf-342fe1bdd598	1
1716270	petrolatum 65 % Topical Cream	PSN	b4e90178-b6c6-49c0-b0b6-b4e73eca2094	1
1716270	petrolatum 65 % Topical Cream	PSN	e76e2f90-8c10-4354-8dfe-b4358018645c	1
1716270	petrolatum 650 MG/ML Topical Cream	SCD	1af2e6c9-aa62-43a3-9eaf-342fe1bdd598	1
1716270	petrolatum 650 MG/ML Topical Cream	SCD	b4e90178-b6c6-49c0-b0b6-b4e73eca2094	1
1716270	petrolatum 650 MG/ML Topical Cream	SCD	e76e2f90-8c10-4354-8dfe-b4358018645c	1
1716270	petrolatum 65 % Topical Cream	SY	1af2e6c9-aa62-43a3-9eaf-342fe1bdd598	1
1716270	petrolatum 65 % Topical Cream	SY	b4e90178-b6c6-49c0-b0b6-b4e73eca2094	1
1716270	petrolatum 65 % Topical Cream	SY	e76e2f90-8c10-4354-8dfe-b4358018645c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62917-065-02	62917006502	56.6 g in 1 JAR (62917-065-02)	56.6 g	2017-05-01	0000-00-00	No	No	Current
62917-065-08	62917006508	226.7 g in 1 JAR (62917-065-08)	226.7 g	2015-10-23	0000-00-00	No	No	Current
62917-065-14	62917006514	397 g in 1 JAR (62917-065-14)	397 g	2017-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theraplex Healing Emollient	The Theraplex Company, LLC	2017-02-16	HUMAN OTC DRUG LABEL	1
Theraplex Healing Emollient	The Theraplex Company, LLC	2017-02-16	HUMAN OTC DRUG LABEL	1
theraplex HEALING EMOLLIENT	The Theraplex Company, LLC \| Memphis Contract Packaging, Inc.	2015-10-23	HUMAN OTC DRUG LABEL	1