FDA.reportPublic FDA data

Rexall Hemorrhoidal

Product NDC
55910-331
Requested package NDC
55910-331-24
11-digit product format
559100331
Labeler code
55910
Product ID
55910-331_b359104b-8264-40e5-a01e-1eb79997c892
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, and Petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Dolegencorp,LLC
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-03-01
Marketing end
0000-00-00
Substance
GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength
0 mg/g; mg/g; mg/g; mg/g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55910-33155910-331-24IInactivated by FDA2026-10-05

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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-331-24Rexall Hemorrhoidal1 in 1 CARTONCREAM15
55910-331-24Rexall Hemorrhoidal28 g in 1 TUBECREAM285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-331REXALL HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, AND PETROLATUM) CREAM [DOLEGENCORP,LLC]5Legacy NDC, 2 package rows20241222_bf4b6237-90c3-415f-a5dd-e0f777bde60a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-331-24559100331241 TUBE in 1 CARTON (55910-331-24) > 28 g in 1 TUBE1 tube2014-03-010000-00-00NoNoCurrent