Hemorrhoidal

Product NDC: 45802-188
11-digit product format: 458020188
Labeler code: 45802
Product ID: 45802-188_e5fe3ee4-494a-46c4-b806-88d8bf2c6f2d
Type: HUMAN OTC DRUG
Nonproprietary name: mineral oil, petrolatum, phenylephrine HCl
Dosage form: OINTMENT
Route: RECTAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-11-01
Substance: MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 14; 74.9; .25 g/100g; g/100g; g/100g
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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINERAL OIL	14 g/100g
PETROLATUM	74.9 g/100g
PHENYLEPHRINE HYDROCHLORIDE	.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T5L8T28FGP	Internal UNII lookup
4T6H12BN9U	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
1372298	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
43826c68-0a20-460d-a7b5-f3e12395a7d0	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
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
45802-188-16	Hemorrhoidal	57 g in 1 TUBE	OINTMENT	57		5
45802-188-16	Hemorrhoidal	1 in 1 CARTON	OINTMENT	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-188-16	GM - Gram	45802-188	79480cc4-4ca9-4b90-aba7-e524def1312a	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
THYME OIL	INACTIVE INGREDIENT	2UK410MY6B	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
THYME OIL	INACTIVE INGREDIENT	2UK410MY6B	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PERRIGO NEW YORK INC]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-188	HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]	4	Current NDC, Legacy NDC, 2 package rows	20240718_43826c68-0a20-460d-a7b5-f3e12395a7d0.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 9 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots	LIDOCAINE	CVS PHARMACY, INC	caef51a8-76e9-42b3-a160-c54f62b47de1	2026-01-05	Warnings	Exact identifier application number: M015
CVS Maximum OTC Strength Hemorrhoidal with Aloe	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM	CVS PHARMACY,INC	b55c63fb-5dfa-4567-8192-58f403868837	2026-01-02	Warnings	Exact identifier application number: M015
HemRid Anorectal Cream	LIDOCAINE	KKA & Associates LLC	dbeb4325-3e85-1147-e053-2995a90a2160	2025-12-31	Warnings	Exact identifier application number: M015
ElixirCurozole	CLOTRIMAZOLE	ELIXIR HEALTHCARE USA, LLC.	0c468a9e-d092-4704-b742-92ecd9918209	2025-12-26	Warnings	Exact identifier application number: M015
Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE	GRAXCELL PHARMACEUTICAL, LLC	5162baee-0d63-494e-8046-459437b85348	2025-12-25	Warnings	Exact identifier application number: M015
HEMORRHOIDAL	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	Safeway	3e6728b6-26e3-4287-8ba6-e27f305cd93b	2025-12-20	Warnings	Exact identifier application number: M015
PREPARATION H	PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	40fde50a-3cc0-4286-9b33-8f3912254c33	2025-12-18	Warnings	Exact identifier application number: M015
ElixirLidoFast Rapid Relief	GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE	ELIXIR HEALTHCARE USA, LLC.	45de9dfa-6c89-1eae-e063-6294a90a4dac	2025-12-13	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Topco Associates LLC	81a3546b-5099-4b9a-b774-b3e79316b267	2025-12-13	Warnings	Exact identifier application number: M015
Kroger Hemorrhoid	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	Kroger Company	45b2dd86-7fb0-07bf-e063-6394a90a1884	2025-12-11	Warnings	Exact identifier application number: M015
LMX5	LIDOCAINE	Ferndale Laboratories, Inc.	34f8ed6b-4a52-4a99-9c1b-254196dc29b0	2025-12-10	Warnings	Exact identifier application number: M015
PURA	WITCH HAZEL	Mypura.com Limited	1523f52f-6a5b-a12d-e063-6294a90a4496	2025-12-05	Warnings	Exact identifier application number: M015
Menthol and Zinc Oxide	MENTHOL AND ZINC OXIDE	Marlex Pharmaceuticals, Inc.	c24e2dab-cab4-38f4-e053-2995a90aabae	2025-12-04	Warnings	Exact identifier application number: M015
CAREALL Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	New World Imports, Inc	7913bd41-a606-4ca6-b69f-2717c2f54b07	2025-12-01	Warnings	Exact identifier application number: M015
Dr Butlers Hemorrhoid and Fissure PF	LIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25	Beyond Health P.A.	f526199e-5c9e-7a3c-e053-2a95a90aa98e	2025-11-26	Warnings	Exact identifier application number: M015
Meicated Wipe	WITCH HAZEL	Diamond Wipes International, Inc	4458c80c-d013-55ba-e063-6394a90a6b39	2025-11-24	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Trifecta Pharmaceuticals Usa Llc	804d7b1f-1be8-50c9-e053-2a91aa0a35d0	2025-11-18	Warnings	Exact identifier application number: M015
Launch Medical	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	293ef514-44c1-43ac-9a81-c30e34ad39e5	2025-11-12	Warnings	Exact identifier application number: M015
FARGELIN HEMORRHOIDAL	CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE	MADISON ONE ACME INC	6844ad63-512d-496a-9458-011894185b0d	2025-11-10	Warnings	Exact identifier application number: M015
Hazel Perineal Healing Foam	WITCH HAZEL	Jiangsu Senwo Medical Technology Co., Ltd.	314b75cb-affe-a248-e063-6294a90a47b7	2025-11-07	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	105095e3-843e-4153-adc9-266dd14929a2	6
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	105095e3-843e-4153-adc9-266dd14929a2	6
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	105095e3-843e-4153-adc9-266dd14929a2	6
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	43826c68-0a20-460d-a7b5-f3e12395a7d0	5
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	43826c68-0a20-460d-a7b5-f3e12395a7d0	5
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	43826c68-0a20-460d-a7b5-f3e12395a7d0	5
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	485fd02f-bfea-41d0-90a1-f12fcfeb2a15	2
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	485fd02f-bfea-41d0-90a1-f12fcfeb2a15	2
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	485fd02f-bfea-41d0-90a1-f12fcfeb2a15	2
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	88e3624d-b8bb-4e65-9250-4c51d2bbed16	1
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	88e3624d-b8bb-4e65-9250-4c51d2bbed16	1
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	88e3624d-b8bb-4e65-9250-4c51d2bbed16	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-188-16	45802018816	1 TUBE in 1 CARTON (45802-188-16) / 57 g in 1 TUBE	1 tube	2013-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hemorrhoidal Ointment Drug Facts	Sportpharm LLC	2026-02-03	HUMAN OTC DRUG LABEL	1
Hemorrhoidal Ointment Drug Facts	Padagis Israel Pharmaceuticals Ltd	2025-08-22	HUMAN OTC DRUG LABEL	5
Hemorrhoidal Ointment Drug Facts	Bryant Ranch Prepack	2024-08-14	HUMAN OTC DRUG LABEL	2
Perrigo Hemorrhoidal Ointment Drug Facts	Proficient Rx LP	2024-01-01	HUMAN OTC DRUG LABEL	6