Rexall Maximum Strength Hemorrhoidal

Product NDC
55910-402
11-digit product format
559100402
Labeler code
55910
Product ID
55910-402_600fd5a6-bacf-4d4d-b6da-8a1bdca490c0
Type
HUMAN OTC DRUG
Nonproprietary name
PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM
Dosage form
CREAM
Route
TOPICAL
Labeler
Dolgencorp, Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-06-28
Marketing end
0000-00-00
Substance
PRAMOXINE HYDROCHLORIDE; GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55910-402IInactivated by FDA2026-10-12
excluded packagepackage55910-40255910-402-03IInactivated by FDA2026-10-12

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55910-402-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55910-402-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55910-402-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55910-402-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55910-402-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55910-402-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55910-402-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55910-402-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55910-402-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55910-402-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55910-402-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55910-402-03557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55910-402-038af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55910-402-03834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55910-402-031332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55910-402-03fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55910-402-0386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55910-402-03bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55910-402-038dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55910-402-03e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55910-402-039bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55910-402-03110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-402-032019-10-29C16284748780-1960f7f55-dade-8e05-e053-dbdaa90a074adrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-402-03Rexall Maximum Strength Hemorrhoidal28 g in 1 TUBE, WITH APPLICATORCREAM281
55910-402-03Rexall Maximum Strength Hemorrhoidal1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5REXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
GLYCERINACTIVE MOIETYPDC6A3C0OXREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
PETROLATUMACTIVE MOIETY4T6H12BN9UREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
PRAMOXINEACTIVE MOIETY068X84E056REXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311REXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4REXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
LAURETH-23INACTIVE INGREDIENTN72LMW566GREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92REXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3REXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
STEARETH-2INACTIVE INGREDIENTV56DFE46J5REXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08REXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEREXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-402REXALL MAXIMUM STRENGTH HEMORRHOIDAL (PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM) CREAM [DOLGENCORP, INC.]1Legacy NDC, 2 package rows20110727_d56768b7-dc2b-4527-a4ba-d3d462c32be3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSNd56768b7-dc2b-4527-a4ba-d3d462c32be31
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCDd56768b7-dc2b-4527-a4ba-d3d462c32be31
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSYd56768b7-dc2b-4527-a4ba-d3d462c32be31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55910-402-035591004020328 g in 1 TUBE, WITH APPLICATOR28 gHistorical