Curasore

Product NDC: 12258-223
11-digit product format: 122580223
Labeler code: 12258
Product ID: 12258-223_5d4254ae-bfd1-9ccf-e063-6294a90a394b
Type: HUMAN OTC DRUG
Nonproprietary name: Pramoxine Hydrochloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: S.S.S. Company
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1995-08-31
Substance: PRAMOXINE HYDROCHLORIDE
Active strength: 1 g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	12258-223		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	12258-223	12258-223-05	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: Curasore
Listing expiration: 2027-12-31

Active Ingredients#

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

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
12258-223-05	Curasore	15 mL in 1 BOTTLE	LIQUID	15		7
12258-223-05	Curasore	1 in 1 CARTON	LIQUID	1		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pramoxine Hydrochloride	ACTIVE INGREDIENT	88AYB867L5	CURASORE (PRAMOXINE HYDROCHLORIDE) LIQUID [S.S.S. COMPANY]	1
Pramoxine	ACTIVE MOIETY	068X84E056	CURASORE (PRAMOXINE HYDROCHLORIDE) LIQUID [S.S.S. COMPANY]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	CURASORE (PRAMOXINE HYDROCHLORIDE) LIQUID [S.S.S. COMPANY]	1
ether	INACTIVE INGREDIENT	0F5N573A2Y	CURASORE (PRAMOXINE HYDROCHLORIDE) LIQUID [S.S.S. COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12258-223	CURASORE (PRAMOXINE HYDROCHLORIDE) LIQUID [S.S.S. COMPANY]	6	Current NDC, Legacy NDC, 2 package rows	20250119_6891e5aa-e6f2-4355-8ee9-d23c9959787e.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 105 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calypxo Pain Relief	METHYL SALICYLATE, MENTHOL	Advanced Rx of Tennessee, LLC	0b7736df-c7e0-7d00-e063-6294a90aa57e	2024-12-31	Warnings	Exact identifier application number: M017
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	Advanced Rx Pharmacy of Tennessee, LLC	f4bfc4a6-06ef-1f76-e053-2995a90a2b8f	2024-12-31	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	01cb19a4-ce22-144d-e063-6294a90a8aa3	2024-12-31	Warnings	Exact identifier application number: M017
Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream	LIDOCAINE, MENTHOL	Sato Pharmaceutical Co., Ltd.	2251e96b-d050-4ec2-a6b9-6659610885bf	2024-12-30	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Safeway	af2e2ef3-0f3f-4592-8081-b6553ade2f5a	2024-12-26	Warnings	Exact identifier application number: M017
Comforte Menstrual Cramp Relief Cream	MENTHOL	PMS4PMS LLC	c121537e-3333-4f35-8c77-20086158dff4	2024-12-26	Warnings	Exact identifier application number: M017
N-Labs Arcticzen Pain Relief Knee	CAMPHOR (SYNTHETIC), MENTHOL	NUTRIOMO LABS PTE. LTD	05ee574a-854c-4a77-be77-082055075c4d	2024-12-26	Warnings	Exact identifier application number: M017
BiteMD External Analgesic First Aid Antiseptic	BENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOL	United Industries Corporation	4c60db03-6d2b-4ae0-a200-718b3a50eb0f	2024-12-23	Warnings	Exact identifier application number: M017
GNP Anti Itch	CAMPHOR, MENTHOL	AMERISOURCEBERGEN DRUG CORPORATION	b4f2d6f7-2287-47d8-e053-2995a90ae335	2024-12-23	Warnings	Exact identifier application number: M017
cool and heat pain relieving liquid	MENTHOL	Bionpharma Inc.	ec6f59d8-45c5-46a0-e053-2995a90a239f	2024-12-23	Warnings	Exact identifier application number: M017
FOOT WORKS MAXIMUM CRACKED HEEL	BENZALKONIUM CHLORIDE, LIDOCAINE	COSMAX USA, CORPORATION	29f92230-d1d4-5e94-e063-6294a90af812	2024-12-23	Warnings	Exact identifier application number: M017
pain relief roll-on	LIDOCAINE 4%	Bionpharma Inc.	f607b6dc-8d13-604a-e053-2995a90a59ab	2024-12-23	Warnings	Exact identifier application number: M017
Veneno de Abeja Aceite De Vibora Brand	METHYL SALICYLATE	Miramar Cosmetics, Inc DBA Miramar Lab	a6c4889c-e7a9-44b9-bd9a-70fd6e8c4825	2024-12-23	Warnings	Exact identifier application number: M017
Itch Relief	HYDROCORTISONE 1%	Trifecta Pharmaceuticals USA LLC	af5daf6c-bcad-8ebf-e053-2a95a90af1b0	2024-12-20	Warnings	Exact identifier application number: M017
Pain Itch Relief	LIDOCAINE HCI	Trifecta Pharmaceutical USA LLC	f40b19a8-795c-f514-e053-2a95a90a6d15	2024-12-20	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	44d3638d-f29b-0e01-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M017
Rhuli Gel	CAMPHOR, MENTHOL	Trifecta Pharmaceuticals USA, LLC.	4fbb3c23-ed47-336e-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Rugby Laboratories	132982ea-cce6-687c-e063-6294a90a4632	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Pharmacy Value Alliance LLC	9bb98452-a605-5c20-e053-2995a90a1ea7	2024-12-20	Warnings	Exact identifier application number: M017
DCH Cooling Pain Relief	MENTHOL 10.5%	Derma Care Research Labs, LLC	00dcdae0-c744-8402-e063-6294a90a12f8	2024-12-20	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
2109512	CURASORE 1 % Topical Solution	PSN	6891e5aa-e6f2-4355-8ee9-d23c9959787e	7
1294034	pramoxine HCl 1 % Topical Solution	PSN	6891e5aa-e6f2-4355-8ee9-d23c9959787e	7
2109512	pramoxine hydrochloride 10 MG/ML Topical Solution [Curasore]	SBD	6891e5aa-e6f2-4355-8ee9-d23c9959787e	7
1294034	pramoxine hydrochloride 10 MG/ML Topical Solution	SCD	6891e5aa-e6f2-4355-8ee9-d23c9959787e	7
2109512	Curasore 10 MG/ML Topical Solution	SY	6891e5aa-e6f2-4355-8ee9-d23c9959787e	7
1294034	pramoxine hydrochloride 1 % Topical Solution	SY	6891e5aa-e6f2-4355-8ee9-d23c9959787e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12258-223-05	12258022305	1 BOTTLE in 1 CARTON (12258-223-05) / 15 mL in 1 BOTTLE	1 bottle	1995-08-31	0000-00-00	No	No	Current