Peviderm Pramoxine Hydrocholride 1%

Product NDC: 58980-913
11-digit product format: 589800913
Labeler code: 58980
Product ID: 58980-913_119ef16e-c873-41df-9e98-4ccade286a85
Type: HUMAN OTC DRUG
Nonproprietary name: Pramoxine Hydrochloride
Dosage form: LOTION
Route: TOPICAL
Labeler: Stratus Pharmaceuticals Inc
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-11-01
Substance: PRAMOXINE HYDROCHLORIDE
Active strength: 1 mg/mL
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: Peviderm Pramoxine Hydrocholride 1%
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	1 mg/mL

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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
680b40fa-1922-443a-a4b0-7c3f6a2b847d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58980-913-80	Peviderm Pramoxine Hydrocholride 1%	222 mL in 1 BOTTLE	LOTION	222		2
58980-913-80	Peviderm Pramoxine Hydrocholride 1%	1 in 1 BOX	LOTION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58980-913-80	ML - Milliliter	58980-913	7d00e397-db14-47f8-a67d-cbb7e210a158	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58980-913	PEVIDERM PRAMOXINE HYDROCHOLRIDE 1% (PRAMOXINE HYDROCHLORIDE) LOTION [STRATUS PHARMACEUTICALS INC]	2	Current NDC, 2 package rows	20241109_680b40fa-1922-443a-a4b0-7c3f6a2b847d.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 133 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	1dc21c95-b419-4175-85f8-040b73060d37	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Roll-On Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	d94ae654-ce25-4bff-b9bd-24a0e0e8568a	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	f8bff018-fb4f-47b4-b8f8-4a496aede346	2024-03-20	Warnings	Exact identifier application number: M017
Rugby Arthritis Pain Relieving Topical Analgesic	CAPSAICIN	Rugby Laboratories	8f1bc075-97ac-4154-8768-0d878104c3ba	2024-03-14	Warnings	Exact identifier application number: M017
Rugby Ice Blue External Analgesic	MENTHOL, UNSPECIFIED FORM	Rugby Laboratories	2b65cb6a-4364-4770-b7b9-5c4637edd01a	2024-03-14	Warnings	Exact identifier application number: M017
Leader Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	fd06d17f-4dff-42a9-a84f-904809ceb981	2024-03-13	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	EROS GLOBAL	b3495c95-ba4b-9459-e053-2a95a90a710f	2024-03-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	1369e70f-7a61-7078-e063-6394a90a9a88	2024-03-11	Warnings	Exact identifier application number: M017
Pain Reliever Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	130665d6-3de8-cb91-e063-6294a90a2083	2024-03-06	Warnings	Exact identifier application number: M017
Dermachange Aid Anti-Itch	DIPHENHYDRAMINE HCL	Private Label Beauty and Wellness	12ed906c-d028-0ff7-e063-6394a90aaa52	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Cold Therapy	MENTHOL	Private Label Beauty and Wellness	12ef7dd8-3da3-9c87-e063-6394a90ac924	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Arthritis Relief	TROLAMIN SALICYLATE	Private Beauty Label and Wellness	12dbfa50-1b97-f988-e063-6394a90a662c	2024-03-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	b0f4010c-995f-40e1-aa40-92760e697a61	2024-03-02	Warnings	Exact identifier application number: M017
Icy Hot Advanced Relief	CAMPHOR AND MENTHOL	Chattem, Inc.	9979ff36-415b-44e4-bb10-6bf682cd00f9	2024-03-01	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	5051b650-18a4-481e-a8d7-d41d4ae51efd	2024-02-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	2999fecb-cb15-4023-ade4-ab5822b094d5	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8	MENTHOL	Amish Origins Management, LLC	aaad56d5-6737-4edc-af0e-8e207695c0ec	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	b120404f-5a07-4182-bb50-d943418622da	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	437491ca-60ff-4508-b408-f97e7152f638	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	ffe15aed-ea90-4db8-aace-d691a81c05ae	2024-02-29	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58980-913-80	58980091380	1 BOTTLE in 1 BOX (58980-913-80) / 222 mL in 1 BOTTLE	1 bottle	2024-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Peviderm Pramoxine Hydrocholride 1%	Stratus Pharmaceuticals Inc \| Tarmac Products Inc	2024-11-07	HUMAN OTC DRUG LABEL	2