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 7 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.1cada0ae-3f0f-441c-a633-faa0a3009d2b2026-02-05WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINESainite Trading Shenzhen Co., Ltd.49fcbe81-34b6-5906-e063-6294a90aa65b2026-02-04WarningsExact identifier
application number: M015
Perineal Cooling Pad LinersFRIDA MOM PERINEAL COOLING PAD LINERSFridababy, LLCe9d33d92-34ee-b639-e053-2a95a90a9f362026-02-04WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSportpharm LLC88e3624d-b8bb-4e65-9250-4c51d2bbed162026-02-03WarningsExact identifier
application number: M015
careone hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmerican Sales Company46794d2e-8fe6-490d-9cfa-ba9b6c209ad62026-01-29WarningsExact identifier
application number: M015
LUBRICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.9d98afbf-11ce-745b-e053-2a95a90abc142026-01-28WarningsExact identifier
application number: M015
foster and thrive hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLStrategic Sourcing Services LLC9da843f2-e88c-432e-b091-a6acf81d856b2026-01-22WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLHyVee Incbf1beca0-cc9b-4100-9db7-77f2d1e5497c2026-01-21WarningsExact identifier
application number: M015
GRANULOTION HemorrhoidalMENTHOL, ZINC OXIDEGL Health, Inc.1a32741c-5e4a-40e5-b15a-8233c5bdb92b2026-01-19WarningsExact identifier
application number: M015
HydroseptineZINC OXIDE, MENTHOLAKRON PHARMA INC5359d92e-641e-4076-9d91-18daee58a30e2026-01-19WarningsExact identifier
application number: M015
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
application number: M015
WalgreensHEMORRHOIDAL PAIN RELIEFWalgreensb0b1ce47-9fa4-4505-8f38-39a0d500e9f62026-01-15WarningsExact identifier
application number: M015
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
application number: M015
WalgreensHEMORRHOIDAL COOLING GELWalgreens1277d2e8-2a5e-23f5-e063-6294a90a69b02026-01-15WarningsExact identifier
application number: M015
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
application number: M015
MEDPURA Vitamin A and D Vitamin A and DMEDPURA VITAMIN A AND DAkron Pharma Inc.38cc2317-691b-4657-af05-c67623eba7602026-01-14WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens2dd710ac-ab04-4a24-826f-b5a44d0581682026-01-14WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreensca98dea5-767d-49a8-887b-d96cad487fc42026-01-14WarningsExact identifier
application number: M015
Walgreens Moisture BarrierMENTHOL, AND ZINC OXIDEWalgreen Companya6db6f13-4e02-47dc-aef6-a804506c3d8b2026-01-14WarningsExact identifier
application number: M015
GNP Hemorrhoidal Maximum StrengthHEMORRHOIDALAmerisourcebergen Drug Corporation24103355-cd72-55b0-e063-6394a90a90ec2026-01-14WarningsExact 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