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 107 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DCH Calaspray Itch Relief	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Derma Care Research Labs, LLC	fda2afaf-3cd0-92b3-e053-6394a90a7493	2024-12-19	Warnings	Exact identifier application number: M017
DCH Nerve Pain Relief Roll-On	LIDOCAINE HCL 4%, MENTHOL 1%	Derma Care Research Labs, LLC	ff32cbb2-79eb-9158-e053-6394a90ac357	2024-12-19	Warnings	Exact identifier application number: M017
DCH Burn Relief	LIDOCAINE, 0.5%	Derma Care Research Labs	ffd7be08-0510-dfcb-e053-6394a90ad286	2024-12-19	Warnings	Exact identifier application number: M017
DCH Arthritis Pain Relief Roll-On	CAPSAISIN 0.1%	Derma Care Research Labs, LLC	fda0d359-95eb-8b38-e053-6294a90a7b88	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relieving	MENTHOL 2%	Derma Care Research Labs, LLC	ff49ee63-6a87-c7a7-e053-6294a90a77a3	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Pain Relief Roll-On Maximum Strength	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	dd80e560-6467-2166-e053-2995a90a88a8	2024-12-19	Warnings	Exact identifier application number: M017
DCH Labs Cool and Heat Roll-On	MENTHOL 16%	Derma Care Research Labs, LLC	d35d7720-44ce-3624-e053-2995a90a7fb4	2024-12-19	Warnings	Exact identifier application number: M017
Dr Goldsons Pain	MENTHOL 8%, METHYL SALICYLATE 30%	Derma Care Research Labs, LLC	fb34b0d3-ccc0-305e-e053-6394a90a231d	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Pain Relieving	CAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30%	Derma Care Research Labs, LLC	dd06af3c-5452-9759-e053-2a95a90afc21	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Burn Relief Aloe Maximum Strength	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	ec6efa4b-dcbe-1c2b-e053-2995a90ae043	2024-12-19	Warnings	Exact identifier application number: M017
DCH Arthritis Relief	TROLAMIN SALICYLATE 10%	Derma Care Research Labs, LLC	ff31e515-5780-b77d-e053-6394a90af6b9	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relief	LIDOCAINE 4%	Derma Care Research Labs, LLC	00efda74-d434-04be-e063-6294a90a6d98	2024-12-19	Warnings	Exact identifier application number: M017
Dollar General Cold Therapy Pain Relief	MENTHOL 5%	Dolgencorp, LLC	ff3284d1-e73c-93bf-e053-6294a90aaf4e	2024-12-19	Warnings	Exact identifier application number: M017
Dollar General Pain Relieving Patch with Lidocaine	LIDOCAINE	DOLGENCORP, LLC	55828cd1-3a1e-48ac-bb01-4c50b96d09a2	2024-12-19	Warnings	Exact identifier application number: M017
DCH Nerve Pain Relief	LIDOCAINE 4%, MENTHOL 1%	Derma Care Research Labs, LLC	00db480a-e510-a64d-e063-6394a90a4695	2024-12-19	Warnings	Exact identifier application number: M017
Pain, Burn, and Itch Relief	BENZOCAINE 20%, MENTHOL 0.5%	Derma Care Research Labs, LLC	fd9fe09f-3ae9-c5f5-e053-6394a90ad691	2024-12-19	Warnings	Exact identifier application number: M017
DCH Cooling Pain Relief	MENTHOL 4%	Derma Care Research Labs, LLC	00ed3175-c3ba-6545-e063-6394a90acfd1	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relief	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	00dd70f3-ecc3-33ba-e063-6294a90a4f32	2024-12-19	Warnings	Exact identifier application number: M017
Walgreens Kinesiology Pain Relief	LIDOCAINE, MENTHOL	Walgreen Co.	0fdbb310-8e65-4e0c-b413-a093964324a2	2024-12-19	Warnings	Exact identifier application number: M017
Signature Care Medicated Cold and Hot Patch	MENTHOL	Safeway	0335f1b3-5c8a-67b8-e063-6294a90a9847	2024-12-19	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