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 89 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A Health Itch Relief GelITCH RELIEF GELBionpharma, Inc.38040732-48c9-3533-e063-6394a90af10a2025-06-20WarningsExact identifier
application number: M017
SCHOELIF Numbing CreamNUMBING CREAMGuangzhou Qiexiran Cosmetics Co., Ltd.37eaabb7-884e-0bd5-e063-6294a90ae0632025-06-19WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology37ee539c-df7e-511d-e063-6394a90a44692025-06-19WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology37eef80a-556f-b090-e063-6294a90a151b2025-06-19WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology37ef02d4-2ff5-cb23-e063-6294a90a68af2025-06-19WarningsExact identifier
application number: M017
Post-Treatment Repair CreamHYDROCORTISONEVi Medical Products Inc.ab8885a9-0778-28ff-e053-2995a90a2e122025-06-19WarningsExact identifier
application number: M017
MyDermLIDOCAINEInspec Solutions LLC.82d075d1-c92e-2097-e053-2991aa0ab1312025-06-18WarningsExact identifier
application number: M017
Walgreens Extra Small LidocaineLIDOCAINEWalgreen Co.dc838e47-d234-4ba5-9449-f645e99be9232025-06-18WarningsExact identifier
application number: M017
CLn Body MoisturizerCOLLOIDAL OAT MOISTURIZERTopMD Skin Care, Inc.2de3d68d-a540-d456-e063-6394a90a4b572025-06-18WarningsExact identifier
application number: M017
Aloe UP SPF 30 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35967b33-bdfb-ee3c-e063-6294a90a75f62025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35b9dcfa-05f3-3d7b-e063-6394a90a18f12025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 MineralZINC OXIDEAloe International, LLC35bc3621-f4e4-42d3-e063-6394a90a7aad2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDEAloe International, LLC35cd5542-947d-a042-e063-6394a90a13f82025-06-18WarningsExact identifier
application number: M017
Relieve Your PainMENTHOLProximity Capital Partners LLC dba Asutrac12369dd-8305-edaf-e053-2995a90a0d3d2025-06-18WarningsExact identifier
application number: M017
Melt Pain AwayCAPSAICINProximity Capital Partners LLC dba Asutraa95a11d7-a2ae-6654-e053-2a95a90a802c2025-06-18WarningsExact identifier
application number: M017
Recovery Roll-OnMENTHOL, CAMPHORPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRAebc9630f-6d8b-e4f0-e053-2995a90a0b492025-06-18WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37cdfabc-1fdb-246a-e063-6394a90a008a2025-06-17WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37ce6c35-b211-43de-e063-6294a90ab7732025-06-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Sun Pharmaceutical Industries, Inc.312ddc8d-100e-cfac-e063-6294a90acd092025-06-16WarningsExact 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