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 7 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	1cada0ae-3f0f-441c-a633-faa0a3009d2b	2026-02-05	Warnings	Exact identifier application number: M015
Numbing Cream	LIDOCAINE	Sainite Trading Shenzhen Co., Ltd.	49fcbe81-34b6-5906-e063-6294a90aa65b	2026-02-04	Warnings	Exact identifier application number: M015
Perineal Cooling Pad Liners	FRIDA MOM PERINEAL COOLING PAD LINERS	Fridababy, LLC	e9d33d92-34ee-b639-e053-2a95a90a9f36	2026-02-04	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Sportpharm LLC	88e3624d-b8bb-4e65-9250-4c51d2bbed16	2026-02-03	Warnings	Exact identifier application number: M015
careone hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	American Sales Company	46794d2e-8fe6-490d-9cfa-ba9b6c209ad6	2026-01-29	Warnings	Exact identifier application number: M015
LUBRICAINE 5	LIDOCAINE 5%	ESBA LABORATORIES INC.	9d98afbf-11ce-745b-e053-2a95a90abc14	2026-01-28	Warnings	Exact identifier application number: M015
foster and thrive hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	9da843f2-e88c-432e-b091-a6acf81d856b	2026-01-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	HyVee Inc	bf1beca0-cc9b-4100-9db7-77f2d1e5497c	2026-01-21	Warnings	Exact identifier application number: M015 ndc (product): 42507-279
GRANULOTION Hemorrhoidal	MENTHOL, ZINC OXIDE	GL Health, Inc.	1a32741c-5e4a-40e5-b15a-8233c5bdb92b	2026-01-19	Warnings	Exact identifier application number: M015
Hydroseptine	ZINC OXIDE, MENTHOL	AKRON PHARMA INC	5359d92e-641e-4076-9d91-18daee58a30e	2026-01-19	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	HEMORRHOIDAL CREAM	Walgreens	1ac2b2ae-c090-483b-ad2c-1374552add4a	2026-01-15	Warnings	Exact identifier application number: M015
Walgreens	HEMORRHOIDAL PAIN RELIEF	Walgreens	b0b1ce47-9fa4-4505-8f38-39a0d500e9f6	2026-01-15	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	HEMORRHOIDAL CREAM	Walgreens	4276ddad-2363-462a-bb97-574f946ec3f0	2026-01-15	Warnings	Exact identifier application number: M015
Walgreens	HEMORRHOIDAL COOLING GEL	Walgreens	1277d2e8-2a5e-23f5-e063-6294a90a69b0	2026-01-15	Warnings	Exact identifier application number: M015
Hemorrhoid and Fissure	GLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%	FlexiGo Inc	48697377-61c0-1b0a-e063-6294a90a3293	2026-01-15	Warnings	Exact identifier application number: M015
MEDPURA Vitamin A and D Vitamin A and D	MEDPURA VITAMIN A AND D	Akron Pharma Inc.	38cc2317-691b-4657-af05-c67623eba760	2026-01-14	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal	HEMORRHOIDAL RECTAL SUPPOSITORIES	Walgreens	2dd710ac-ab04-4a24-826f-b5a44d058168	2026-01-14	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal	HEMORRHOIDAL RECTAL SUPPOSITORIES	Walgreens	ca98dea5-767d-49a8-887b-d96cad487fc4	2026-01-14	Warnings	Exact identifier application number: M015
Walgreens Moisture Barrier	MENTHOL, AND ZINC OXIDE	Walgreen Company	a6db6f13-4e02-47dc-aef6-a804506c3d8b	2026-01-14	Warnings	Exact identifier application number: M015
GNP Hemorrhoidal Maximum Strength	HEMORRHOIDAL	Amerisourcebergen Drug Corporation	24103355-cd72-55b0-e063-6394a90a90ec	2026-01-14	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