Rexall Hemorrhoidal

Product NDC: 55910-331
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55910-331		I	Inactivated by FDA		2026-10-05
excluded package	package	55910-331	55910-331-24	I	Inactivated by FDA		2026-10-05

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

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55910-331-24	Rexall Hemorrhoidal	1 in 1 CARTON	CREAM	1		5
55910-331-24	Rexall Hemorrhoidal	28 g in 1 TUBE	CREAM	28		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-331	REXALL HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, AND PETROLATUM) CREAM [DOLEGENCORP,LLC]	5	Legacy NDC, 2 package rows	20241222_bf4b6237-90c3-415f-a5dd-e0f777bde60a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-331-24	55910033124	1 TUBE in 1 CARTON (55910-331-24) > 28 g in 1 TUBE	1 tube	2014-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rexall ® Hemorrhoidal Cream Topical	Dolegencorp,LLC \| Natureplex LLC	2024-12-17	HUMAN OTC DRUG LABEL	5