Hemorrhoidal Cream

Product NDC: 0363-0641
11-digit product format: 003630641
Labeler code: 0363
Product ID: 0363-0641_485ea437-c84b-ce0f-e063-6394a90acfae
Type: HUMAN OTC DRUG
Nonproprietary name: Hemorrhoidal Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: Walgreens
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-03-25
Substance: PETROLATUM; GLYCERIN; PRAMOXINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 150; 144; 10; 2.5 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: 2027-12-31
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: Hemorrhoidal Cream
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PETROLATUM	150 mg/g
GLYCERIN	144 mg/g
PRAMOXINE HYDROCHLORIDE	10 mg/g
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T6H12BN9U	Internal UNII lookup
PDC6A3C0OX	Internal UNII lookup
88AYB867L5	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1293649	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1ac2b2ae-c090-483b-ad2c-1374552add4a	Available on FDA.report

DailyMed Product Concepts#

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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0641-09	Hemorrhoidal Cream	1 in 1 PACKAGE	CREAM	1	6
0363-0641-10	Hemorrhoidal Cream	25.5 g in 1 TUBE	CREAM	25.5	6
0363-0641-18	Hemorrhoidal Cream	1 in 1 PACKAGE	CREAM	1	5
0363-0641-19	Hemorrhoidal Cream	51 g in 1 TUBE	CREAM	51	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0641	HEMORRHOIDAL CREAM CREAM [WALGREENS]	5	Current NDC, Legacy NDC, 2 package rows	20241227_1ac2b2ae-c090-483b-ad2c-1374552add4a.zip
0363-0641	HEMORRHOIDAL CREAM CREAM [WALGREENS]	4	Current NDC, Legacy NDC, 2 package rows	20241227_4276ddad-2363-462a-bb97-574f946ec3f0.zip

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 20 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Preparation H Cooling Gel	PHENYLEPHRINE HCL, WITCH HAZEL	Haleon US Holdings LLC	cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4	2024-04-05	Warnings	Exact identifier application number: M015
PREPARATION H Maximum Strength	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	Haleon US Holdings LLC	7cc03d2e-e708-589a-d9bb-58ebbda989c0	2024-04-05	Warnings	Exact identifier application number: M015
Preparation H	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL	Haleon US Holdings LLC	2f370875-0225-47b7-b43f-8fa4600d2a0e	2024-04-05	Warnings	Exact identifier application number: M015
PREPARATION H	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	a23ded81-78ba-c199-a8f0-aaf360b216ff	2024-03-02	Warnings	Exact identifier application number: M015
PREPARATION H MEDICATED WIPES	WITCH HAZEL	Haleon US Holdings LLC	3b1cfa8a-942f-471e-b7c0-744f83b687a0	2024-03-02	Warnings	Exact identifier application number: M015
PREPARATION H HYDROCORTISONE	HYDROCORTISONE	Haleon US Holdings LLC	b8d531eb-4012-0450-0e4b-70a808464041	2024-02-29	Warnings	Exact identifier application number: M015
PREPARATION H	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Haleon US Holdings LLC	507c08ab-a98b-33fe-e2ac-eb9b9a810d5a	2024-02-29	Warnings	Exact identifier application number: M015
Preparation H Rapid Relief	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	27db1d58-4609-4a80-af2f-9e36f10482e1	2024-02-29	Warnings	Exact identifier application number: M015
Preparation H Rapid Relief	GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	699310e8-1a93-40b4-a8f4-a765be4a0cb1	2024-02-29	Warnings	Exact identifier application number: M015
Numquick Analgesic	EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE	Unit Dose, Ltd.	b66e7a91-9e35-64dd-e053-2a95a90a8b83	2024-02-28	Warnings	Exact identifier application number: M015
Medicated Wipes Hemorroidal Wipes With Witch Hazel	WITCH HAZEL	Wuhan Zonsen Medical Products Co., Ltd.	12441e46-5490-d45c-e063-6394a90a39e3	2024-02-26	Warnings	Exact identifier application number: M015
Lidocaine Hemorrhoid	LIDOCAINE HCL, PHENYLEPHRINE HCL, WITCH HAZEL	Walgreens Co	10a47899-f4a0-66e8-e063-6394a90a11dd	2024-02-05	Warnings	Exact identifier application number: M015
ER Hemorrhoid	PHENYLEPHRINE HCL	EVER READY FIRST AID	3cf29fc0-af4d-4610-a426-894601d5e078	2024-02-02	Warnings	Exact identifier application number: M015
RRHOID RAGE Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	POPPY COLLECTIVE LLC	a02a6398-0acd-4aa7-8320-ac586ff12eb3	2024-01-31	Warnings	Exact identifier application number: M015
No More Products	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Sarati International, Inc	102e7dbb-06dc-f4d1-e063-6394a90aa3eb	2024-01-26	Warnings	Exact identifier application number: M015
Pranicura 5	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Sarati International, Inc.	0fe10710-ac59-4fc5-e063-6294a90a48fc	2024-01-26	Warnings	Exact identifier application number: M015
Prosoria Anti-Itch Moisturizer	PRAMOXINE HYDROCHLORIDE	Nuvothera, Inc.	3c4b9515-f435-4227-a347-d6508778426d	2024-01-10	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Cardinal Health 110 dba LEADER	a5a261c2-1f36-c895-e053-2a95a90ab22b	2024-01-02	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Proficient Rx LP	105095e3-843e-4153-adc9-266dd14929a2	2024-01-01	Warnings	Exact identifier application number: M015
Family Wellness HEMORRHOID	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	FAMILY DOLLAR (Family Wellness)	16ceb129-5c0a-428a-a867-cfbbb08bb62a	2023-12-11	Warnings	Exact identifier application number: M015

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1293649	glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal Cream	PSN	1ac2b2ae-c090-483b-ad2c-1374552add4a	6
1293649	glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream	SCD	1ac2b2ae-c090-483b-ad2c-1374552add4a	6
1293649	glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal Cream	SY	1ac2b2ae-c090-483b-ad2c-1374552add4a	6
1293649	glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal Cream	PSN	4276ddad-2363-462a-bb97-574f946ec3f0	5
1293649	glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream	SCD	4276ddad-2363-462a-bb97-574f946ec3f0	5
1293649	glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal Cream	SY	4276ddad-2363-462a-bb97-574f946ec3f0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0641-09	00363064109	1 TUBE in 1 PACKAGE (0363-0641-09) / 25.5 g in 1 TUBE (0363-0641-10)	1 tube	2018-03-25	0000-00-00	No	No	Current
0363-0641-10	00363064110	25.5 g in 1 TUBE	25.5 g					Historical
0363-0641-18	00363064118	1 TUBE in 1 PACKAGE (0363-0641-18) / 51 g in 1 TUBE (0363-0641-19)	1 tube	2018-03-25	0000-00-00	No	No	Current
0363-0641-19	00363064119	51 g in 1 TUBE	51 g					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Walgreens ® Hemorrhoidal M/S Cream 0.9oz	Walgreens \| Unipack LLC	2026-01-15	HUMAN OTC DRUG LABEL	6
Walgreens ® Hemorrhoidal M/S Cream 1.8oz	Walgreens \| Unipack LLC	2026-01-15	HUMAN OTC DRUG LABEL	5