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 104 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANTI ITCH	HYDROCORTISONE	Safeway	0bfa1653-76b7-48ed-a896-a0b5fc3bd794	2025-01-08	Warnings	Exact identifier application number: M017
Sting Relief Swab	BENZOCAINE	Epic Medical Supply Corp	259fbfe4-d67c-ea1e-e063-6294a90a0fb0	2025-01-07	Warnings	Exact identifier application number: M017
Sinsin Mulpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	22ea8a51-fdee-4650-abf8-f996268c9303	2025-01-07	Warnings	Exact identifier application number: M017
SINSINPAP COOL	LEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUS	Sinsin Pharmaceutical Co., Ltd.	9d47855f-ccb5-4557-a31a-a2b336fa9806	2025-01-07	Warnings	Exact identifier application number: M017
Burn Jel	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	ff621b46-2342-41db-994d-851a09796d08	2025-01-06	Warnings	Exact identifier application number: M017
Lidocare Arm, Neck, Leg	4% LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	59a104ee-7034-99c3-e053-2991aa0a164c	2025-01-06	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE Pain Relieving	LIDOCAINE	Hisamitsu Pharmaceutical Co., Inc.	4f3a438c-f378-4d2a-a95c-58e56cf1e797	2025-01-06	Warnings	Exact identifier application number: M017
Lidocare 03	4% LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	416ebf5a-2efb-6d0b-e054-00144ff88e88	2025-01-06	Warnings	Exact identifier application number: M017
AVCOO Pain Relief Roll-on	MENTHOL	ADP Health Limited	e0bb77b2-45ee-45fa-9659-9c7d99bb20dc	2025-01-05	Warnings	Exact identifier application number: M017
health and beyond BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	0b6bb3ed-50fb-40c4-acb6-ae3f16031531	2025-01-05	Warnings	Exact identifier application number: M017
glo SKIN BEAUTY Remedy Gel	GLO SKIN BEAUTY REMEDY GEL	Hayden Caleel LLC	aa47ff08-07b3-4fd1-bae5-420e4b928f06	2025-01-05	Warnings	Exact identifier application number: M017
Capsaicin 0.025% Cream	CAPSAICIN 0.025%	Puretek Corporation	28f00df0-c416-f17b-e063-6294a90a5570	2025-01-02	Warnings	Exact identifier application number: M017
AVON HeXashield Pain Relief for Muscle, Back and Joint Cream	CAMPHOR, MENTHOL, METHYL SALICYLATE	Tai Guk Pharm. Co., Ltd.	8f29ffd7-48b9-109f-e053-2995a90ab215	2025-01-01	Warnings	Exact identifier application number: M017
AVON HeXashield Arthritis Pain Relief Cream Capsaisin	CAPSAISIN	Tai Guk Pharm. Co., Ltd.	8f286a9d-8765-21b3-e053-2a95a90ae43a	2025-01-01	Warnings	Exact identifier application number: M017
AVON HeXashield Anti Itch Cream with Healing Aloe	HYDROCORTISONE	Tai Guk Pharm. Co., Ltd.	8f2aa11d-d794-6f3e-e053-2995a90a1d9d	2025-01-01	Warnings	Exact identifier application number: M017
HeXashield Anti Itch Cream with Healing Aloe	HYDROCORTISONE	Tai Guk Pharm. Co., Ltd.	b9d033f3-4d12-a2c8-e053-2995a90ac7f1	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Pain Relief with Menthol	MENTHOL	Green Compass, Inc.	0a0c212e-ae5d-8505-e063-6394a90af622	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	0a0b688e-50f1-3eb1-e063-6394a90a7efa	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Topical Pain	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	8cb80362-5d24-1ee3-e053-2a95a90afcdf	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Roll-On Pain Relief	MENTHOL	Green Compass, Inc.	b5916aa2-428c-5637-e053-2995a90a08b0	2025-01-01	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