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 2 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Numb520Spray	LIDOCAINE, PHENYLEPHRINE HCL	Ebanel Laboratories, Inc.	350f0e25-fbdc-c0c0-e063-6294a90a50a0	2026-08-20	Warnings	Exact identifier application number: M015
Gembooxt Topical Numbing Cream	LIDOCAINE	Guangdong Quadrant Ecological Technology Co., Ltd.	49951a3e-3b62-3d66-e063-6294a90a9360	2026-08-12	Warnings	Exact identifier application number: M015
NumbMD Lidocaine Cream Anorectal(hemorrhoidal)	LIDOCAINE 5%	EveryMarket Inc	52379055-d017-4d98-e063-6294a90a196c	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD Lidocaine Cream	LIDOCAINE 5%	EveryMarket Inc	52369a41-820d-cd7a-e063-6394a90ac6d1	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD Lidocaine Cream	LIDOCAINE 5%	EveryMarket Inc	51d370b4-1c34-d203-e063-6394a90a80b1	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD 5% Lidocaine cream	LIDOCAINE 5%	EveryMarket Inc	507d0c2c-9517-40f8-e063-6394a90a1996	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)	LIDOCAINE CREAM ANORECTAL	EveryMarket Inc	483d81a3-7493-3391-e063-6394a90a2e3d	2026-08-12	Warnings	Exact identifier application number: M015
Numbing Cream	LIDOCAINE	100 KARMA INC	35b5ba9d-da1d-55d6-e063-6294a90a5fa8	2026-08-12	Warnings	Exact identifier application number: M015
Treatonic hemorrhoid treatment	5% LIDOCAINE	100 KARMA INC	41442fa7-c511-07ca-e063-6294a90a3992	2026-08-12	Warnings	Exact identifier application number: M015
Lidocaine numbing cream	5% LIDOCAINE	100 KARMA INC	47380721-6633-4a50-e063-6394a90aca94	2026-08-12	Warnings	Exact identifier application number: M015
Treatonic 5% Lidocaine Cream	5% LIDOCAINE CREAM	100 KARMA INC	47dc7630-9a74-1989-e063-6294a90a50bb	2026-08-12	Warnings	Exact identifier application number: M015
Treatonic 5% Lidocaine Cream	5% LIDOCAINE CREAM	100 KARMA INC	49e6b69f-bd6e-b415-e063-6394a90a8e65	2026-08-12	Warnings	Exact identifier application number: M015
Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing	LIDOCAINE	Putian Licheng District Zhijiancheng Trading Co., Ltd.	4a7be9eb-5e57-90e8-e063-6394a90aad9e	2026-08-08	Warnings	Exact identifier application number: M015
THE SOLU TION	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDE	SCALP TECH INC	58793581-8826-9a74-e063-6294a90a2465	2026-08-06	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	5457b3d7-e6b6-34a7-e063-6394a90aa240	2026-08-03	Warnings	Exact identifier application number: M015
HEMORRHOIDALCREAMPROCURE	PHENYLEPHRINE HCL, PETROLATUM, MINERAL OIL	TWIN MED, LLC	e9c44756-1c98-41be-e053-2995a90a35b4	2026-08-03	Warnings	Exact identifier application number: M015
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	YYBA CORP	582a0001-da1e-909a-e063-6394a90a2b11	2026-08-03	Warnings	Exact identifier application number: M015
up and up	PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	b42775ae-44fe-487e-b9ca-21d9687020a9	2026-07-29	Warnings	Exact identifier application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	578fa642-ff30-e511-e063-6294a90a5987	2026-07-26	Warnings	Exact identifier application number: M015
CVS Topical Anesthetic Hemorrhoidal	DIBUCAINE	CVS PHARMACY, INC	9f3d4fdb-ad82-4ab8-8a9e-252d027068ab	2026-07-25	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