FDA.reportPublic FDA data

Pramoxine Hydrochloride Anorectal

Product NDC
58980-522
11-digit product format
589800522
Labeler code
58980
Product ID
58980-522_a3ed95de-1df1-46d0-bc60-938274ffbc7d
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Stratus Pharmaceuticals
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-01
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
Pramoxine Hydrochloride Anorectal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246075Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
39a16b66-b0e9-412f-8773-8dec0a1227e0Available on FDA.report

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
58980-522-40Pramoxine Hydrochloride Anorectal118 mL in 1 BOTTLELOTION1181
58980-522-40Pramoxine Hydrochloride Anorectal1 in 1 BOXLOTION11
58980-522-80Pramoxine Hydrochloride Anorectal1 in 1 BOXLOTION11
58980-522-80Pramoxine Hydrochloride Anorectal237 mL in 1 BOTTLELOTION2371

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-522-40ML - Milliliter58980-52272a6d420-a262-40fa-a252-a1469ba5e42112025-12-16
58980-522-80ML - Milliliter58980-5221959a263-db44-4ed5-ad03-bd25e51ed62c12025-12-16

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 15 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BODY ACTION PRODUCTS Anal Glide ExtraBENZOCAINEPRODUCT MAX GROUP INC282ac8d3-2caf-42de-b347-450e9c7a9e502025-04-03WarningsExact identifier
application number: M015
Numb 520LIDOCAINEClinical Resolution Laboratory, Inc.984c4bee-0d44-4e0f-a057-0d54400c4cac2025-04-02WarningsExact identifier
application number: M015
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
application number: M015
HemAwayLIDOCAINEMelaleuca, Inc.cf842adf-fcd7-2c8c-e053-2995a90adea62025-03-27WarningsExact identifier
application number: M015
Numb and Number Anorectal CreamLIDOCAINEDermtech Labs, Inc31420635-5021-173d-e063-6294a90a407a2025-03-26WarningsExact identifier
application number: M015
Leader Maximum Strength Hemorrhoidal ReliefLIDOCAINECardinal Health,Inc.65c780b0-7f47-4ae9-a847-c22deaaa28882025-03-21WarningsExact identifier
application number: M015
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
application number: M015
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
application number: M015
Numbskin Maximum Strength Pain RelieverLIDOCAINEShinpharma Inc2f288bde-99fd-42f8-e063-6394a90a0f052025-02-27WarningsExact identifier
application number: M015
PREPARATION H TOTABLES IRRITATION RELIEF WIPESWITCH HAZELHaleon US Holdings LLC1953ec64-20ce-488b-8f14-44e15cc9e7202025-02-21WarningsExact identifier
application number: M015
LBRI STOP THE PAIN Super Aloe Pain Relief CreamMENTHOL, METHYL SALICYLATEL'BRI HEALTH AND BEAUTY INC62e18a37-c0db-4b1e-a6a1-35684cc00e082025-01-28WarningsExact identifier
application number: M015
HemorrhoidalPAIN RELIEFNeilMed Pharmaceuticals Inc.038a2cf5-1b72-227b-e063-6394a90a84ad2025-01-24WarningsExact identifier
application number: M015
lidocaineLIDOCAINENivagen Pharmaceuticals, Inc.32964ec3-1880-477b-9f71-2222c39106aa2025-01-23WarningsExact identifier
application number: M015
Hemorrhoidal cocoa butterHEMORRHOIDALNeilMed Pharmaceuticals Inc.03b159b0-b960-b38d-e063-6394a90a94622025-01-17WarningsExact identifier
application number: M015
Gentle Laxative BisacodylGENTLE LAXATIVE BISACODYLNeilMed Pharmaceuticals Inc03b3733a-4d78-149f-e063-6294a90a65182025-01-17WarningsExact identifier
application number: M015
Glycerin LaxativeGLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEFNeilMed Pharmaceuticals Inc.03b4be69-6488-76be-e063-6394a90a7edf2025-01-17WarningsExact identifier
application number: M015
Pre-moistened Medicated Wipes, Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent, Walgreens Pre-moistened Medicated Wipes, Walgreens Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal AstringentWITCH HAZELWalgreens Company209a111b-d169-cb5d-e063-6394a90a33ca2025-01-15WarningsExact identifier
application number: M015
Pre-moistened Medicated Pads, Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel, Walgreens Pre-moistened Medicated Pads, Walgreens Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch HazelWITCH HAZELWalgreens Company1e2dcec1-a1fe-71d2-e063-6394a90a99082025-01-15WarningsExact identifier
application number: M015
AER Pre-moistened Witch Hazel PadWITCH HAZELBirchwood Laboratories LLC1cca622f-0a6b-4f35-9355-34c249ee705e2025-01-14WarningsExact identifier
application number: M015
B-SURE Traveler ToweletteB-SURE TRAVELERBirchwood Laboratories LLCe1a5da94-6a1a-497b-a737-1c1541bf04042025-01-14WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246075pramoxine HCl 1 % Topical LotionPSN39a16b66-b0e9-412f-8773-8dec0a1227e01
1246075pramoxine hydrochloride 10 MG/ML Topical LotionSCD39a16b66-b0e9-412f-8773-8dec0a1227e01
1246075pramoxine hydrochloride 1 % Topical LotionSY39a16b66-b0e9-412f-8773-8dec0a1227e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58980-522-40589800522401 BOTTLE in 1 BOX (58980-522-40) / 118 mL in 1 BOTTLE1 bottle2025-11-01NoNoCurrent
58980-522-80589800522801 BOTTLE in 1 BOX (58980-522-80) / 237 mL in 1 BOTTLE1 bottle2025-11-01NoNoCurrent