FDA.reportPublic FDA data

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct12258-223UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage12258-22312258-223-05UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…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
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 g/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12258-223-05Curasore15 mL in 1 BOTTLELIQUID157
12258-223-05Curasore1 in 1 CARTONLIQUID17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L5CURASORE (PRAMOXINE HYDROCHLORIDE) LIQUID [S.S.S. COMPANY]1
PramoxineACTIVE MOIETY068X84E056CURASORE (PRAMOXINE HYDROCHLORIDE) LIQUID [S.S.S. COMPANY]1
alcoholINACTIVE INGREDIENT3K9958V90MCURASORE (PRAMOXINE HYDROCHLORIDE) LIQUID [S.S.S. COMPANY]1
etherINACTIVE INGREDIENT0F5N573A2YCURASORE (PRAMOXINE HYDROCHLORIDE) LIQUID [S.S.S. COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12258-223CURASORE (PRAMOXINE HYDROCHLORIDE) LIQUID [S.S.S. COMPANY]6Current NDC, Legacy NDC, 2 package rows20250119_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 33 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol Precise Cooling Pain RelievingLIDOCAINE, MENTHOLKenvue Brands LLCfc0a3404-b174-3952-e053-6294a90a1e022026-02-16WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCLValu Merchandisers Company87ee2b4f-d640-4cec-9f48-1d8aa54434e92026-02-16Warnings, Adverse reactionsExact identifier
application number: M017
Hemp Magic Fast-Acting Pain Relief CreamMENTHOLNexxus Capital LLC4af69640-1413-868b-e063-6394a90a39892026-02-16WarningsExact identifier
application number: M017
RelaxInk LIDOCAINELIDOCAINE 4%Hambli Limited49a1cf66-9bb1-b918-e063-6394a90a2ff62026-02-15WarningsExact identifier
application number: M017
blue goo Pain RelievingMENTHOL 2.5%Garcoa, Inc.7b9b5ac6-9568-464c-8096-0302a1e650df2026-02-13WarningsExact identifier
application number: M017
Methyl Salicylate 30 Percent CreamMETHYL SALICYLATEAlexso, Inc1d50ccb2-1a5d-49c7-8524-2f54eed63e852026-02-13WarningsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLTopco Associates LLCa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLTopco Associates LLC80962394-a46f-48fd-8e0c-685dd1e500d72026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
BanophenDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMajor Pharmaceuticals9758d886-bd58-4eb2-a827-fa8e7fee2b7c2026-02-13WarningsExact identifier
application number: M017
Natureplex Hydrocortisone HydroHYDROCORTISONENatureplex, LLC2fc6a148-34bb-4289-8588-32c1bb011b982026-02-13WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINAlexso, Inc6d0bc1cc-e812-4753-b20c-c0357dd6deb52026-02-13WarningsExact identifier
application number: M017
Swiftalyn Numbing CreamLIDOCAINE 4%GENUINE INNOVATION LTD3f74c4a6-26f0-ddf7-e063-6394a90a12252026-02-12WarningsExact identifier
application number: M017
PHARMBANNER Arnica Bruise CreamARNICA BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3c783061-8e2d-8a84-e063-6394a90a52652026-02-12WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAIN RELIEF WITH HEMPMENTHOL, CAMPHORWorldwide Cosmetics, Inc459d64a9-0538-57c8-e063-6394a90a61552026-02-12WarningsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOLWalgreen Co.cba60e9d-5f12-4c56-9fa5-6ce1514fc2b02026-02-12Warnings, Adverse reactionsExact identifier
application number: M017
Medicated Body PowderMENTHOLWalmart Stores Incafd337b7-d76e-f17a-e053-2a95a90abac72026-02-12WarningsExact identifier
application number: M017
Lidocaine Hydrochloride 2%LIDOCAINE HYDROCHLORIDEAldermed Inc.4977b722-d08d-3d9e-e063-6294a90a90352026-02-12WarningsExact identifier
application number: M017
Ice Gel ICE COLD ANALGESICMENTHOLJell Pharmaceuticals Pvt Ltd4a8b3f84-8c45-eb94-e063-6394a90a3e732026-02-11WarningsExact identifier
application number: M017
Walgreens Pain Relieving Lidocaine PatchLIDOCAINEWalgreen Co.41c4e9fe-e407-b22a-e063-6394a90a4b272026-02-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CREAM 1%Aldermed Inc.4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d2026-02-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2109512CURASORE 1 % Topical SolutionPSN6891e5aa-e6f2-4355-8ee9-d23c9959787e7
1294034pramoxine HCl 1 % Topical SolutionPSN6891e5aa-e6f2-4355-8ee9-d23c9959787e7
2109512pramoxine hydrochloride 10 MG/ML Topical Solution [Curasore]SBD6891e5aa-e6f2-4355-8ee9-d23c9959787e7
1294034pramoxine hydrochloride 10 MG/ML Topical SolutionSCD6891e5aa-e6f2-4355-8ee9-d23c9959787e7
2109512Curasore 10 MG/ML Topical SolutionSY6891e5aa-e6f2-4355-8ee9-d23c9959787e7
1294034pramoxine hydrochloride 1 % Topical SolutionSY6891e5aa-e6f2-4355-8ee9-d23c9959787e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12258-223-05122580223051 BOTTLE in 1 CARTON (12258-223-05) / 15 mL in 1 BOTTLE1 bottle1995-08-310000-00-00NoNoCurrent