Hemorrhoidal cooling gel

Product NDC: 0363-9712
11-digit product format: 003639712
Labeler code: 0363
Product ID: 0363-9712_0bbdecbd-91ce-600d-e063-6294a90a4ca4
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine HCl, Witch hazel
Dosage form: GEL
Route: TOPICAL
Labeler: WALGREENS
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-01-15
Substance: PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
Active strength: 2.5; 500 mg/g; mg/g
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 cooling gel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/g
WITCH HAZEL	500 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup
101I4J0U34	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
249465	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
03bbe258-e00d-13cc-e063-6394a90ae345	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-9712-01	Hemorrhoidal cooling gel	1 in 1 CARTON	GEL	1		2
0363-9712-01	Hemorrhoidal cooling gel	26 g in 1 TUBE	GEL	26		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9712	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREENS]	2	Current NDC, 2 package rows	20240115_03bbe258-e00d-13cc-e063-6394a90ae345.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 16 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calmoseptine	ANORECTAL OINTMENT	Calmoseptine Inc.	ff9539ed-d9ae-401d-adbc-df8f1d751431	2025-01-13	Warnings	Exact identifier application number: M015
Dibucaine	DIBUCAINE	Akron Pharma Inc.	60469e43-ab6f-46d3-a1df-00e58275f565	2025-01-12	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Chain Drug Marketing Association Inc.	2b490a08-149d-76ab-e063-6394a90a084f	2025-01-09	Warnings	Exact identifier application number: M015
Drs. pharmacy HEMORRHOIDAL COOLING	PHENYLEPHRINE HCL, WITCH HAZEL	OL PHARMA TECH, LLC Drs PHARMACY	d6f6b482-d85d-001c-e053-2995a90ad98c	2025-01-09	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream with Aloe	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Chain Drug Marketing Association	2b33c710-ac17-20f9-e063-6294a90ad29c	2025-01-08	Warnings	Exact identifier application number: M015
THE SOLUTION	LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE	SCALP TECH INC	df51623c-e0b6-8e86-e053-2995a90a59b2	2025-01-08	Warnings	Exact identifier application number: M015
frida mom Perineal Cooling Pad Liners	WITCH HAZEL	Fridababy, LLC	a461ff3d-e115-4f15-a545-bacb502ff6cd	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Postpartum Recovery Essentials	WITCH HAZEL	Fridababy, LLC	2d26c6f2-5d31-4c07-9f40-2fbfcfbf1234	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Perineal Healing	WITCH HAZEL	Fridababy, LLC	6a58e2a8-c4d5-4078-b5f4-28504de1f020	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Labor and Delivery Plus Postpartum Recovery	WITCH HAZEL	Fridababy, LLC	4b5fc312-4c8c-4396-a70c-b1ed129038c7	2024-12-30	Warnings	Exact identifier application number: M015
Tucks Triple Relief Hemorrhoidal	WHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Blistex Inc.	bf892e90-2d9b-4fa0-8ee4-8a2736be6c30	2024-12-24	Warnings	Exact identifier application number: M015
BLISS GVS HEMORRHOIDAL	PHENYLEPHRINE HCL	Bliss GVS Pharma Limited	fceea303-2ea0-10e9-e053-6294a90a5492	2024-12-21	Warnings	Exact identifier application number: M015
Dibucaine	DIBUCAINE 1%	Geri-Care Pharmaceuticals, Corp	afe88610-5cac-960e-e053-2a95a90a7ba4	2024-12-20	Warnings	Exact identifier application number: M015
Hemorroidal Cooling gel	PHENYLEPHRINE, WITCH HAZEL	Pharmacy Value Alliance, LLC	7276aab8-0297-2a55-e053-2a91aa0a8d21	2024-12-20	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Pharmacy Value Alliance, LLC	3803a61b-308a-14a9-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M015
Bliss GVS Hemorrhoidal	HARD FAT, PHENYLEPHRINE HCL	Bliss GVS Pharma Limited	88c49f6c-2a48-2dae-e053-2a95a90af20a	2024-12-19	Warnings	Exact identifier application number: M015
Rectal Care Cream Revivol	LIDOCAINE 5%	Derma Care Research Labs	a1c75161-f84a-e996-e053-2a95a90ac0c5	2024-12-19	Warnings	Exact identifier application number: M015
DCH Numbing Relief	LIDOCAINE 5%	Derma Care Research Labs, LLC	ffd70a31-7d0c-d2d0-e053-6394a90a8674	2024-12-19	Warnings	Exact identifier application number: M015
DCH Hemorrhoidal	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Derma Care Research Labs, LLC	0050701f-4393-3f01-e063-6394a90a4e0e	2024-12-19	Warnings	Exact identifier application number: M015
Moshe Numbing Hemorrhoidal	LIDOCAINE 5%	Derma Care Research Labs	fbd5b488-1921-e9b7-e053-6294a90aba70	2024-12-19	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
101I4J0U34	WITCH HAZEL		WITCH HAZEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
249465	phenylephrine HCl 0.25 % / witch hazel 50 % Rectal Gel	PSN	03bbe258-e00d-13cc-e063-6394a90ae345	2
249465	phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal Gel	SCD	03bbe258-e00d-13cc-e063-6394a90ae345	2
249465	phenylephrine 0.25 % / witch hazel 50 % Rectal Gel	SY	03bbe258-e00d-13cc-e063-6394a90ae345	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0363-9712-01	00363971201	1 TUBE in 1 CARTON (0363-9712-01) / 26 g in 1 TUBE	1 tube	2024-01-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Walgreens Hemmorhoidal Cooling Gel	WALGREENS \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2023-12-05	HUMAN OTC DRUG LABEL	2