Repara

Product NDC: 68345-818
11-digit product format: 683450818
Labeler code: 68345
Product ID: 68345-818_1af9e8e1-3f2a-4b9b-93fd-e0588feec24d
Type: HUMAN OTC DRUG
Nonproprietary name: Lanolin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: PSS World Medical, Inc.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-08-06
Marketing end: 0000-00-00
Substance: LANOLIN
Active strength: 5 g/10g
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68345-818		I	Inactivated by FDA	2026-08-10
excluded package	package	68345-818	68345-818-25	I	Inactivated by FDA	2026-08-10
excluded package	package	68345-818	68345-818-26	I	Inactivated by FDA	2026-08-10

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 · 66 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	68345-818-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68345-818-26	`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	68345-818-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68345-818-26	`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	68345-818-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68345-818-26	`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	68345-818-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68345-818-26	`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	68345-818-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68345-818-26	`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	68345-818-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68345-818-26	`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	68345-818-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68345-818-26	`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	68345-818-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68345-818-26	`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	68345-818-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68345-818-26	`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	68345-818-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68345-818-26	`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	68345-818-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68345-818-26	`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	68345-818-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68345-818-26	`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	68345-818-25	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68345-818-26	`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	68345-818-25	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68345-818-26	`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	68345-818-25	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68345-818-26	`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	68345-818-25	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68345-818-26	`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	68345-818-25	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68345-818-26	`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	68345-818-25	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68345-818-26	`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	68345-818-25	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68345-818-26	`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	68345-818-25	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68345-818-26	`e2bbac7714bc…`	`27bdfed8d636…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68345-818-25	2019-11-27	C162847	48780-1	9855e2a2-5136-60a7-e053-dbdaa90a05bd	3e4b7a53-2690-45c8-824f-44a8508d6944
68345-818-26	2019-11-27	C162847	48780-1	9855e2a2-5136-60a7-e053-dbdaa90a05bd	3e4b7a53-2690-45c8-824f-44a8508d6944

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68345-818-25	Repara	5 g in 1 PACKAGE	OINTMENT	5	2
68345-818-25	Repara	144 in 1 CARTON	OINTMENT	144	2
68345-818-26	Repara	114 g in 1 TUBE	OINTMENT	114	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LANOLIN	ACTIVE INGREDIENT	7EV65EAW6H	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2
LANOLIN	ACTIVE MOIETY	7EV65EAW6H	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2
HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID	INACTIVE INGREDIENT	R79J91U341	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2
OXYQUINOLINE	INACTIVE INGREDIENT	5UTX5635HP	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68345-818	REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]	2	Legacy NDC, 3 package rows	20140807_3e4b7a53-2690-45c8-824f-44a8508d6944.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7EV65EAW6H	LANOLIN	8006-54-0	LANOLIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
853167	lanolin 50 % Topical Ointment	PSN	3e4b7a53-2690-45c8-824f-44a8508d6944	2
853167	lanolin 0.5 MG/MG Topical Ointment	SCD	3e4b7a53-2690-45c8-824f-44a8508d6944	2
853167	lanolin 50 % Topical Ointment	SY	3e4b7a53-2690-45c8-824f-44a8508d6944	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68345-818-25	68345081825	5 g in 1 PACKAGE	5 g	Historical
68345-818-26	68345081826	114 g in 1 TUBE	114 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Repara - PSS World Medical, Inc. \| Summit Industries Inc.	PSS World Medical, Inc. \| Summit Industries Inc.	2014-08-07	HUMAN OTC DRUG LABEL	2