Pramoxine Itch relief

Product NDC: 51316-141
11-digit product format: 513160141
Labeler code: 51316
Product ID: 51316-141_28f13725-48d9-8774-e063-6394a90a6704
Type: HUMAN OTC DRUG
Nonproprietary name: Pramoxine HCl 1%
Dosage form: CREAM
Route: TOPICAL
Labeler: CVS
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-04-25
Substance: PRAMOXINE HYDROCHLORIDE
Active strength: 1 g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Pramoxine Itch relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1052684	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e947694c-c122-0291-e053-2995a90ac39a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51316-141-12	Pramoxine Itch relief	340 g in 1 JAR	CREAM	340		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-141	PRAMOXINE ITCH RELIEF (PRAMOXINE HCL 1%) CREAM [CVS]	3	Current NDC, 1 package rows	20241213_e947694c-c122-0291-e053-2995a90ac39a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 122 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
anti itch	HYDROCORTISONE	Meijer, Inc.	2db7bcab-acb8-48ad-8cd1-842ff7765ed9	2024-10-23	Warnings	Exact identifier application number: M017
NATUREANCE MIRACLE	MENTHOL	EROS GLOBAL CORP	ec1a2a1f-a38d-9c59-e053-2a95a90ad268	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Plantar Relief Strips	CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	65e142d8-da21-4c55-9faf-b387cb6c2c0e	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	cc011b79-2761-40f7-8142-88f8e30a179a	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Profoot, Inc.	06f82bde-41a1-35f6-e063-6394a90a6437	2024-10-23	Warnings	Exact identifier application number: M017
Deep Cover Bug Bite Relief	BENZOCAINE	Morrisons Outdoors, LLC	25010dd6-fb48-8ee7-e063-6394a90aee6c	2024-10-21	Warnings	Exact identifier application number: M017
Evel Knievels Natural Choice Pain Relief	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	4576656c-4b6e-6965-7665-6c52756c6573	2024-10-21	Warnings	Exact identifier application number: M017
berkley and jensen anti itch	HYDROCORTISONE	BJWC	5cc6e4f6-c62d-4923-9726-9dbc569a3f49	2024-10-19	Warnings	Exact identifier application number: M017
DG Health Hydrocortisone Maximum Strength	HYDROCORTISONE	Dolgencorp Inc	2cc792b8-dce6-4178-bd6d-63ba268b7747	2024-10-19	Warnings	Exact identifier application number: M017
Careland Hydrogel Pain Relief Patches	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	e970070c-1c3b-49f0-8298-e6c5ebbf50a0	2024-10-18	Warnings	Exact identifier application number: M017
Fruit of the Earth Cool Blue Aloe Mist Continuous	LIDOCAINE HYDROCHLORIDE	Fruit Of The Earth, Inc.	d4caae4c-efba-2453-e053-2995a90a5e5f	2024-10-18	Warnings	Exact identifier application number: M017
CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving	LIDOCAINE HCL	CVS Pharmacy	f0f1969d-10e0-76ee-e053-2995a90a7336	2024-10-17	Warnings	Exact identifier application number: M017
Wong To Yick External Analgesic	CAMPHOR MENTHOL METHYL SALICYLATE	Wong To Yick Wood Lock Ointment Ltd	16a21af4-6bc0-4ae1-aa3b-1da84c8286e2	2024-10-17	Warnings	Exact identifier application number: M017
Wong To Yick External Analgesic	CAMPHOR MENTHOL METHYL SALICYLATE	Wicsun Trading Inc	0b4bd444-b3c1-47aa-a7e3-f16c92326124	2024-10-17	Warnings	Exact identifier application number: M017
Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL	LIDOCAINE	Fruit of the Earth, Inc.	c7a833bd-7457-73a3-e053-2a95a90ac53f	2024-10-17	Warnings	Exact identifier application number: M017
Wegmans Aloe After Sun Gel with Lidocaine HCl External Analgesic	LIDOCAINE HYDROCHLORIDE	WEGMANS FOOD MARKETS INC	f70bc438-7ed8-f74d-e053-6394a90a2b3f	2024-10-16	Warnings	Exact identifier application number: M017
EQUATE Sunburn relief with Aloe After Sun	LIDOCAINE	Wal-Mart Stores Inc	c25e1288-7ac6-41fc-ab65-26c379f288a7	2024-10-16	Warnings	Exact identifier application number: M017
Genuine First Aid Insect Sting Relief Pad 1 ct	BENZOCAINE, ALCOHOL	GFA Production (Xiamen) Co., Ltd.	b119ba37-0ee1-851a-e053-2995a90a85b1	2024-10-15	Warnings	Exact identifier application number: M017
PAIN RELIEF PATCHES	LIDOCAINE	Walgreen Company	1a587e6e-88d1-4b01-abad-9a365dc64a4d	2024-10-15	Warnings	Exact identifier application number: M017
TopCare Everyday After Sun Cooling	LIDOCAINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	baff7293-e1a3-d1f2-e053-2995a90a93ca	2024-10-15	Warnings	Exact identifier application number: M017

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
1052684	pramoxine HCl 1 % Topical Cream	PSN	e947694c-c122-0291-e053-2995a90ac39a	3
1052684	pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	e947694c-c122-0291-e053-2995a90ac39a	3
1052684	pramoxine hydrochloride 1 % Topical Cream	SY	e947694c-c122-0291-e053-2995a90ac39a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51316-141-12	51316014112	340 g in 1 JAR (51316-141-12)	340 g	2023-04-25	No	No	Current