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 135 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ralli Rapid Pain Relief Roll on	MENTHOL	Troy Manufacturing, Inc.	978d5c2c-fdc4-4d25-83ec-0b9404ec8018	2024-02-19	Warnings	Exact identifier application number: M017
1168	1168 BURN SPRAY	Dynarex Corporation	1183a4f5-f875-dfb0-e063-6394a90af35f	2024-02-16	Warnings	Exact identifier application number: M017
Pain Relief	BENZOCAINE	Safetec of America, Inc.	de84e598-d047-4fae-b2ed-155a3788bc6f	2024-02-16	Warnings	Exact identifier application number: M017
No Mess Hydrocortisone Applicator	HYDROCORTISONE	Walgreen Co.	cfefb517-9099-41c4-8a95-74414ca4032c	2024-02-16	Warnings	Exact identifier application number: M017
Analgesic Balm	MENTHOL 10%, METHYL SALICYLATE 15%	Geri-Care Pharmaceuticals, Corp	ab9bf09d-bc8c-6d17-e053-2995a90a6c36	2024-02-14	Warnings	Exact identifier application number: M017
Natures Oil 16% Menthol	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	2fbe23b7-23a3-4f0b-bc08-0205256f5d68	2024-02-14	Warnings	Exact identifier application number: M017
Rugby Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Rugby Laboratories	4c11876c-57ec-4429-a8c4-fb95baa4074a	2024-02-13	Warnings	Exact identifier application number: M017
Itch stopping Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	11368823-d4af-a536-e063-6294a90a7a2e	2024-02-12	Warnings	Exact identifier application number: M017
Walgreens Boil Pain Relief	BOIL PAIN RELIEF	Walgreens Company	d11bd769-68d0-4057-bc2a-72719f16011e	2024-02-12	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	Rugby Laboratories	c5915c84-84a2-46f6-9f97-0d9873e9944a	2024-02-12	Warnings	Exact identifier application number: M017
Leader Ice Blue Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	952e56ea-5cbc-4078-bd01-5d3b6864a5ce	2024-02-09	Warnings	Exact identifier application number: M017
Leader Ultra Strength Muscle Rub Topical Analgesic	CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE	Cardinal Health, 110 dba LEADER	9d99a900-60e0-454c-98e0-2c63eb910cf1	2024-02-09	Warnings	Exact identifier application number: M017
Pain Relieving	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	28821ffa-a138-47b5-8857-beadf7a20d43	2024-02-08	Warnings	Exact identifier application number: M017
Menthol Camphor Cough Suppressant Topical Analgesic Rub	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	fd0ea70a-ef12-48b1-8d9d-cc5f6417f854	2024-02-08	Warnings	Exact identifier application number: M017
Pain Relieving Cooling	MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	3574d48a-b546-4ea7-b470-071bb328de64	2024-02-08	Warnings	Exact identifier application number: M017
Advil Targeted Relief	CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE	Haleon US Holdings LLC	16e6be21-7b43-443a-89ec-3bdf0ec0dfc1	2024-02-08	Warnings	Exact identifier application number: M017
POINT RELIEF COLD SPOT Pain Relieving	MENTHOL	FABRICATION ENTERPRISES	96f1d592-6cec-412e-a5fd-cf3c4f68644f	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	1c5eb3b3-79b3-472a-ae36-ec6a7dc72925	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	8eb3e7e2-26e5-430e-89aa-40a0367c637e	2024-02-07	Warnings	Exact identifier application number: M017
Nova Natura Topical Analgesic	CAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATE	SEYITLER KIMYA SANAYI ANONIM SIRKETI	abf00f73-f0b1-439e-85aa-bbce8a1ec920	2024-02-06	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