hemorrhoidal

Product NDC: 42507-279
11-digit product format: 425070279
Labeler code: 42507
Product ID: 42507-279_d0bcb196-b9a5-47ed-9f48-70ffa8025370
Type: HUMAN OTC DRUG
Nonproprietary name: cocoa butter, phenylephrine HCl
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: HyVee Inc
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-03-28
Substance: COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 2211; 6.5 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 24 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42507-279-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42507-279-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42507-279-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42507-279-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42507-279-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42507-279-53	`cdf11ea48f46…`	`ba0047e9e063…`
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	42507-279-53	`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	42507-279-53	`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	42507-279-53	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42507-279-53	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42507-279-53	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42507-279-53	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COCOA BUTTER	2211 mg/1
PHENYLEPHRINE HYDROCHLORIDE	6.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
512OYT1CRR	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
1438497	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
bf1beca0-cc9b-4100-9db7-77f2d1e5497c	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
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
42507-279-53	hemorrhoidal	12 in 1 CARTON	SUPPOSITORY	12		4
42507-279-53	hemorrhoidal	1 in 1 BLISTER PACK	SUPPOSITORY	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COCOA BUTTER	ACTIVE INGREDIENT	512OYT1CRR	HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [HYVEE INC]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [HYVEE INC]	1
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [HYVEE INC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [HYVEE INC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [HYVEE INC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [HYVEE INC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [HYVEE INC]	1

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 8 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hemorrhoid, Fissure, ProctalgiaSuppositories	CARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL	WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.	1d40d16a-ee52-463a-e063-6394a90a6077	2026-01-14	Warnings	Exact identifier application number: M015
Hemorrhoid, Fissure, Proctalgia Relief Wash	CARBON, PANTHENOL, SODIUM HYALURONATE	WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.	1e20de39-45b0-54ec-e063-6294a90a04ed	2026-01-14	Warnings	Exact identifier application number: M015
Hemorrhoid, Fissure, Proctalgia Ointments	CARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL, GLYCERIN	WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.	1efe43d5-a29b-5cb2-e063-6394a90aca66	2026-01-14	Warnings	Exact identifier application number: M015
LONAZEM	MENTHOL,PETROLATUM	PEER PHARM LTD.	91f7a741-4178-4639-9cd5-746a4b9a21bf	2026-01-12	Warnings	Exact identifier application number: M015
Hemorrhoidal Hygiene pads	WITCH HAZEL	Akron Pharma Inc.	936a0cca-5049-4ddf-9581-75c2da6d9cfa	2026-01-12	Warnings	Exact identifier application number: M015
Signature numbing cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	4805ba4e-45d3-bf0a-e063-6294a90a6eef	2026-01-10	Warnings	Exact identifier application number: M015
THE SOLUTION 2.0	LIDOCAINE	SCALP TECH INC	0fa423b6-cc0f-b569-e063-6294a90a239e	2026-01-09	Warnings	Exact identifier application number: M015
BLACK LABEL B NUMB	LIDOCAINE HYDROCHLORIDE	SCALP TECH INC	11fcf401-0891-04bc-e063-6294a90a8ad5	2026-01-09	Warnings	Exact identifier application number: M015
GOLD LABEL B NUMB	LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE	SCALP TECH INC	1211590a-13b5-2e75-e063-6394a90a0f86	2026-01-09	Warnings	Exact identifier application number: M015
0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	Universal Distribution Center LLC	90844919-f16a-4390-9dca-b0405b501445	2026-01-08	Warnings	Exact identifier application number: M015
Signature numbing cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	47dda425-86d8-441e-e063-6294a90a0f9a	2026-01-08	Warnings	Exact identifier application number: M015
AER Traveler Towelette	AER TRAVELER	Birchwood Laboratories LLC	26556b9b-1c3a-6cf5-e063-6394a90ab26c	2026-01-08	Warnings	Exact identifier application number: M015
Preparation H Rapid Relief	GLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	49a93cfc-4ccd-4ef3-928f-901b9926f794	2026-01-08	Warnings	Exact identifier application number: M015
PREPARATION H FOR WOMEN	WITCH HAZEL	Haleon US Holdings LLC	a9099cf4-4e2e-4cf1-a52f-48f8e174cb15	2026-01-08	Warnings	Exact identifier application number: M015
LIPOCAINE 5	LIDOCAINE 5%	ESBA LABORATORIES INC.	849d6e28-a6b8-7f49-e053-2a91aa0a497d	2026-01-08	Warnings	Exact identifier application number: M015
TOPICAINE 5	LIDOCAINE 5%	ESBA LABORATORIES INC.	15d33ff7-34ed-253d-e054-00144ff88e88	2026-01-08	Warnings	Exact identifier application number: M015
Dr Wellskin Numbing Cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	47ebedc5-caf1-a774-e063-6394a90ae14d	2026-01-08	Warnings	Exact identifier application number: M015
Dr. Care Numbing Cream	LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	47c94198-7718-bbc2-e063-6294a90a48f1	2026-01-07	Warnings	Exact identifier application number: M015
Healthwise Anorectal Pain Relief	LIDOCAINE 5%	Veridian Healthcare	19c24e1b-a31b-478b-a48b-c39bb4753ca7	2026-01-06	Warnings	Exact identifier application number: M015
Good Sense Hemorrhoidal Maximum Strength Pain Relief	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	L. Perrigo Company	1d6142b6-3746-46f1-99ec-4b19d26f056e	2026-01-06	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
512OYT1CRR	COCOA BUTTER	8002-31-1	COCOA BUTTER
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	PSN	bf1beca0-cc9b-4100-9db7-77f2d1e5497c	4
1438497	cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository	SCD	bf1beca0-cc9b-4100-9db7-77f2d1e5497c	4
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	SY	bf1beca0-cc9b-4100-9db7-77f2d1e5497c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42507-279-53	42507027953	12 BLISTER PACK in 1 CARTON (42507-279-53) / 1 SUPPOSITORY in 1 BLISTER PACK	12 blister pack	2015-03-28	No	No	Current