Hemorrhoidal

Product NDC: 13709-319
11-digit product format: 137090319
Labeler code: 13709
Product ID: 13709-319_2c7264d0-e726-00c1-e063-6394a90af070
Type: HUMAN OTC DRUG
Nonproprietary name: Pain Relief
Dosage form: OINTMENT
Route: RECTAL
Labeler: NeilMed Pharmaceuticals Inc.
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-08-22
Substance: PHENYLEPHRINE HYDROCHLORIDE; PETROLATUM; MINERAL OIL
Active strength: 2.5; 749; 140 mg/g; 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13709-319-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13709-319-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13709-319-01	`0efc9e666f02…`	`f202fb6c5f17…`

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
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/g
PETROLATUM	749 mg/g
MINERAL OIL	140 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup
4T6H12BN9U	Internal UNII lookup
T5L8T28FGP	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
038a2cf5-1b72-227b-e063-6394a90a84ad	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13709-319-01	2025-02-01	C162847	48780-1	2cef2736-6419-d83d-e063-dadaa90ab31f	038a2cf5-1b72-227b-e063-6394a90a84ad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13709-319-01	Hemorrhoidal	57 g in 1 TUBE	OINTMENT	57		3
13709-319-01	Hemorrhoidal	1 in 1 CARTON	OINTMENT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13709-319	HEMORRHOIDAL (PAIN RELIEF) OINTMENT [NEILMED PHARMACEUTICALS INC.]	3	Current NDC, 2 package rows	20250131_038a2cf5-1b72-227b-e063-6394a90a84ad.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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL

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	038a2cf5-1b72-227b-e063-6394a90a84ad	3
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	038a2cf5-1b72-227b-e063-6394a90a84ad	3
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	038a2cf5-1b72-227b-e063-6394a90a84ad	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
13709-319-01	13709031901	1 TUBE in 1 CARTON (13709-319-01) / 57 g in 1 TUBE	1 tube	2023-08-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hemorrhoidal - NeilMed Pharmaceuticals Inc.	NeilMed Pharmaceuticals Inc.	2025-01-24	HUMAN OTC DRUG LABEL	3