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

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 1 of 22 · 425 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-08-03WarningsExact identifier
application number: M015
HEMORRHOIDALCREAMPROCUREPHENYLEPHRINE HCL, PETROLATUM, MINERAL OILTWIN MED, LLCe9c44756-1c98-41be-e053-2995a90a35b42026-08-03WarningsExact identifier
application number: M015
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEYYBA CORP582a0001-da1e-909a-e063-6394a90a2b112026-08-03WarningsExact identifier
application number: M015
up and upPHENYLEPHRINE HYDROCHLORIDETarget Corporationb42775ae-44fe-487e-b9ca-21d9687020a92026-07-29WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd578fa642-ff30-e511-e063-6294a90a59872026-07-26WarningsExact identifier
application number: M015
CVS Topical Anesthetic HemorrhoidalDIBUCAINECVS PHARMACY, INC9f3d4fdb-ad82-4ab8-8a9e-252d027068ab2026-07-25WarningsExact identifier
application number: M015
Moisture BarrierMENTHOL 0.44%, ZINC OXIDE 20.6%Walgreen Company258f3392-0f42-21e8-e063-6294a90ae9ad2026-07-22WarningsExact identifier
application number: M015
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEKORVIA GLOBAL Inc.5690db03-4d62-9660-e063-6394a90a2fc02026-07-14WarningsExact identifier
application number: M015
Gembooxt Topical Numbing CreamLIDOCAINE HCLGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-07-13WarningsExact identifier
application number: M015
Zmztuhua Numbing CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.56417dc6-c14b-ad17-e063-6294a90af7e52026-07-10WarningsExact identifier
application number: M015
Tina Davies IceCreamLIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC6a2b3199-f405-4455-9a02-8885d24eef9c2026-07-09WarningsExact identifier
application number: M015
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
application number: M015
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc561c601f-c2cd-f09c-e063-6294a90adb452026-07-08WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELH E B09b814f4-86b5-4810-bf52-cc88396451c22026-07-07Warnings, Adverse reactionsExact identifier
application number: M015
Witch HazelWITCH HAZELADUSA Distribution, LLCc50d0496-6f09-43c2-9383-3250885968c92026-06-29Warnings, Adverse reactionsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd55260a3e-637a-c53b-e063-6394a90a1b092026-06-27WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens20c41406-99b2-bc89-e063-6294a90aed732026-06-25WarningsExact identifier
application number: M015
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
application number: M015
tina davies IceCream HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd2026-06-24WarningsExact 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