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 147 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BODY ACTION PRODUCTS Endless Love for Men	BENZOCAINE	PRODUCT MAX GROUP INC	d0fa792d-dc04-4bdf-a22d-dea896beae5b	2023-11-10	Warnings	Exact identifier application number: M017
Endless Love For Men	BENZOCAINE	Body Action Products, Inc	4e89cd3a-ecad-44c3-acb3-6d0810add8c0	2023-11-10	Warnings	Exact identifier application number: M017
BODY ACTION PRODUCTS Higher Control Male Climax	BENZOCAINE	PRODUCT MAX GROUP INC	3c7fa73b-abe8-4a8d-951c-4e785d6e812c	2023-11-10	Warnings	Exact identifier application number: M017
Uber Numb	LIDOCAINE HYDROCHLORIDE	UBERScientific, LLC	65a319a6-89d2-44c9-81d5-30327f9948cb	2023-11-10	Warnings	Exact identifier application number: M017
Uber Numb	LIDOCAINE HYDROCHLORIDE	UBERScientific, LLC	768f3f0e-1add-404f-b869-00a9f35ad34a	2023-11-10	Warnings	Exact identifier application number: M017
Zcaine Fast Acting Anesthetic	LIDOCAINE	PHI, Inc	d072243f-6ba6-4ab6-8ebf-a2381fa9c2df	2023-11-09	Warnings	Exact identifier application number: M017
Plum Smooth Plumb Numb Gelee	LIDOCAINE	Universal Companies, Inc.	6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e	2023-11-09	Warnings	Exact identifier application number: M017
Sonacaine Topical Anesthetic With Menthol	LIDOCAINE	Filltech USA, LLC	ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	2023-11-09	Warnings	Exact identifier application number: M017
Bed Bug Instant Bite Relief	LIDOCAINE	P.F. Harris Mfg. Co. LLC	7f472fd0-5605-4cc6-b4b2-1267e815255c	2023-11-09	Warnings	Exact identifier application number: M017
Valtrum Aerobic Sports	SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)	LABORATORIOS QUANTIUM LLC	33f2491e-c1f2-4e5a-acbe-8ace844b88d6	2023-11-09	Warnings	Exact identifier application number: M017
Valtrum Topical Analgesic Roll On	SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)	LABORATORIOS QUANTIUM LLC	28167e2a-9afb-44e7-90c7-9577df9504b6	2023-11-09	Warnings	Exact identifier application number: M017
Satohap Cool Type	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	fe07a00a-2699-44d3-887d-bd068948ad7b	2023-11-07	Warnings	Exact identifier application number: M017
Hims Delay Wipes	BENZOCAINE WIPES	Hims Inc.	adbead3d-dca0-4919-b688-44c88f779e5a	2023-11-07	Warnings	Exact identifier application number: M017
Bakers Best Maximum Strength Pain Relief	LIDOCAINE HYDROCHLORIDE, MENTHOL	Baker's Best Health Products, LLC	9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d	2023-11-06	Warnings	Exact identifier application number: M017
BAKERS BEST Pain Relief with Pure Hemp Seed Oil	LIDOCAINE HYDROCHLORIDE, MENTHOL	BAKER'S BEST HEALTH PRODUCTS, INC.	ae54c234-bfe4-4a74-b293-db7efda7884b	2023-11-06	Warnings	Exact identifier application number: M017
Arth RX Topical Analgesic	METHYL NICOTINATE, CAPSAICIN	HCD Sales	a7b3b9b4-b1c4-4e51-8e3a-c84f64c75609	2023-11-06	Warnings	Exact identifier application number: M017
BAKERS BEST Arthritis Pain Relief Cream with Hemp and Lavender	HISTAMINE DIHYDROCHLORIDE	BAKER'S BEST HEALTH PRODUCTS, INC.	03ec87c5-6669-4afb-8d9c-c8dc9907495d	2023-11-06	Warnings	Exact identifier application number: M017
DOCTORS TOUCH Erase The Pain	MENTHOL	DOCTOR'S CHOICE MEDICAL, LLC	fe9ce2c7-d6af-4dad-b6e6-5049a9e091b0	2023-11-06	Warnings	Exact identifier application number: M017
RadiaGuard Advanced Radiation Relief	LIDOCAINE HYDROCHLORIDE	SMOOTH SIDE, INC	21205087-5a2e-41a5-be40-30cba2895408	2023-11-06	Warnings	Exact identifier application number: M017
BLUE SPRING Foot and Leg Comfort	MENTHOL	ACA MANAGEMENT LLC	5f52218d-eea4-4640-b820-84c077ab98ba	2023-11-06	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