Freds Medicated anti itch

Product NDC: 11383-265
11-digit product format: 113830265
Labeler code: 11383
Product ID: 11383-265_8697e70b-a9a0-8c9a-e053-2991aa0a9b8e
Type: HUMAN OTC DRUG
Nonproprietary name: Pramoxine hydrochloride, menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: Weeks and Leo, Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-04-13
Marketing end: 0000-00-00
Substance: PRAMOXINE HYDROCHLORIDE; MENTHOL
Active strength: 1 g/100g; 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	11383-265		I	Inactivated by FDA	2026-08-03
excluded product	product	11383-265		I	Inactivated by FDA	2026-08-03
excluded package	package	11383-265	11383-265-01	I	Inactivated by FDA	2026-08-03
excluded package	package	11383-265	11383-265-51	I	Inactivated by FDA	2026-08-03

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 · 40 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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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	11383-265-51	`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 product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	11383-265-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	11383-265-51	`8dfbde2a14a4…`	`c9ff85d89658…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11383-265-01	2022-01-21	C162847	48780-1	ba0f9c33-5874-a910-e053-dadaa90a0b85	Armand Medicated Anti itch Cream
11383-265-01	2021-01-29	C162847	48780-1	ba0f9c33-5874-a910-e053-dadaa90a0b85	Armand Medicated Anti itch Cream
11383-265-51	2021-01-29	C162847	48780-1	ba0f9c33-116d-a910-e053-dadaa90a0b85	Armand Medicated Anti itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11383-265-01	Freds Medicated anti itch	1 in 1 CARTON	CREAM	1	8
11383-265-01	Freds Medicated anti itch	28 g in 1 TUBE	CREAM	28	8
11383-265-51	Freds Medicated anti itch	28 g in 1 TUBE	CREAM	28	5
11383-265-51	Freds Medicated anti itch	1 in 1 CARTON	CREAM	1	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11383-265	FREDS MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [WEEKS AND LEO, INC.]	8	Legacy NDC, 2 package rows	20241210_8697e625-4c77-3ad6-e053-2991aa0ae50e.zip
11383-265	FREDS MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [WEEKS AND LEO, INC.]	5	Legacy NDC, 2 package rows	20190416_86986d05-8830-0853-e053-2a91aa0a4b14.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1116155	menthol 1 % / pramoxine HCl 1 % Topical Cream	PSN	8697e625-4c77-3ad6-e053-2991aa0ae50e	8
1116155	menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	8697e625-4c77-3ad6-e053-2991aa0ae50e	8
1116155	menthol 1 % / pramoxine hydrochloride 1 % Topical Cream	SY	8697e625-4c77-3ad6-e053-2991aa0ae50e	8
1116155	menthol 1 % / pramoxine HCl 1 % Topical Cream	PSN	86986d05-8830-0853-e053-2a91aa0a4b14	5
1116155	menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	86986d05-8830-0853-e053-2a91aa0a4b14	5
1116155	menthol 1 % / pramoxine hydrochloride 1 % Topical Cream	SY	86986d05-8830-0853-e053-2a91aa0a4b14	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
11383-265-01	11383026501	1 in 1 CARTON		Historical
11383-265-51	11383026551	28 g in 1 TUBE	28 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Armand Medicated Anti itch Cream	Weeks and Leo, Inc. \| Weeks & Leo, Inc.	2024-12-08	HUMAN OTC DRUG LABEL	8
Armand Medicated Anti itch Cream	Weeks and Leo, Inc. \| Weeks & Leo, Inc.	2019-04-15	HUMAN OTC DRUG LABEL	5