Hemorrhoidal

Product NDC: 42507-944
11-digit product format: 425070944
Labeler code: 42507
Product ID: 42507-944_cfe1c8bb-b48e-4329-8c1b-b93e75b02d56
Type: HUMAN OTC DRUG
Nonproprietary name: glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
Dosage form: CREAM
Route: TOPICAL
Labeler: HyVee Inc
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-08-11
Substance: GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM
Active strength: 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], 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	42507-944-24	`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	42507-944-24	`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	42507-944-24	`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	42507-944-24	`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	42507-944-24	`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	42507-944-24	`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	42507-944-24	`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	42507-944-24	`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	42507-944-24	`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	42507-944-24	`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	42507-944-24	`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	42507-944-24	`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
GLYCERIN	14.4 g/100g
PHENYLEPHRINE HYDROCHLORIDE	.25 g/100g
PRAMOXINE HYDROCHLORIDE	1 g/100g
PETROLATUM	15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PDC6A3C0OX	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup
88AYB867L5	Internal UNII lookup
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1293649	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
b867f691-7a13-4659-b664-06aa36899310	Available on FDA.report

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYCERIN	ACTIVE INGREDIENT	PDC6A3C0OX	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
GLYCERIN	ACTIVE MOIETY	PDC6A3C0OX	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
LAURETH-23	INACTIVE INGREDIENT	N72LMW566G	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
STEARETH-2	INACTIVE INGREDIENT	V56DFE46J5	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
STEARETH-20	INACTIVE INGREDIENT	L0Q8IK9E08	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [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 14 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	4eb3c9ac-268a-5246-e054-00144ff88e88	2025-06-09	Warnings	Exact identifier application number: M015
Bunnies Bum Anorectal Numbing	LIDOCAINE	FloCal Distributors LLC	3712e151-d171-1c5d-e063-6294a90a36c0	2025-06-08	Warnings	Exact identifier application number: M015
RECOVERY Numbing	LIDOCAINE HCL	Renu Laboratories, LLC	e4e05cae-56a6-b2b3-e053-2a95a90a104b	2025-06-06	Warnings	Exact identifier application number: M015
Hemorrohoid Master Cream	LIDOCAINE, PHENYLEPHRINE HCL	Ebanel Laboratories, Inc.	36eccc74-107e-3914-e063-6294a90a1856	2025-06-06	Warnings	Exact identifier application number: M015
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	36c9988b-9e61-ebbf-e063-6394a90a4114	2025-06-04	Warnings	Exact identifier application number: M015
Hemorrhoid Master	LIDOCAINE, PHENYLEPHRINE HCL	Clinical Resolution Laboratory, Inc.	36caf20d-116a-f86a-e063-6294a90a7b62	2025-06-04	Warnings	Exact identifier application number: M015
Quick Numb	LIDOCAINE	Clinical Resolution Laboratory, Inc.	351b95a6-e038-d9aa-e063-6294a90a4172	2025-05-29	Warnings	Exact identifier application number: M015
Dibucaine Topical Anesthetic 1% Hemorrhoidal	DIBUCAINE	Rugby Laboratories Inc.	f23c8cd1-98f9-41cd-84d4-cf01c2ede29a	2025-05-29	Warnings	Exact identifier application number: M015
The Femme Fix Hemorrhoid Treatment	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	POPPY COLLECTIVE LLC	5217b5d9-b835-4428-a6b3-e6b255630742	2025-05-27	Warnings	Exact identifier application number: M015
MAXOCAINE Topical Anesthetic Anorectal	LIDOCAINE	PRIME COMMERCE, LLC	26e8c867-8cb8-4a25-91b1-da45a1edd09a	2025-05-27	Warnings	Exact identifier application number: M015
Numb25	LIDOCAINE	Ebanel Laboratories, Inc.	35107403-55ae-c627-e063-6394a90a0b5c	2025-05-27	Warnings	Exact identifier application number: M015
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	350e4d5e-dac7-ae4e-e063-6394a90a76b4	2025-05-27	Warnings	Exact identifier application number: M015
Numb25	LIDOCAINE 5%	Ebanel Laboratories, Inc	350fd302-8fd5-5288-e063-6294a90aa382	2025-05-27	Warnings	Exact identifier application number: M015
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	35095bed-0e91-c44a-e063-6294a90add6e	2025-05-27	Warnings	Exact identifier application number: M015
Numb520	LIDOCAINE	Clinical Resolution Laboratory, Inc.	a0411950-c6ee-4427-acb6-3cef58b0e93e	2025-05-15	Warnings	Exact identifier application number: M015
Numb25	LIDOCAINE	Clinical Resolution Laboratory, Inc.	cfcb839d-47b4-4925-bb30-97b64d20d2b3	2025-05-15	Warnings	Exact identifier application number: M015
Numb520	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Clinical Resolution Laboratory, Inc.	65d3b614-361d-4fb9-9583-a95be754bc82	2025-05-15	Warnings	Exact identifier application number: M015
Chamosyn	BARRIER CREAM	Links Medical Products	f9dfb2d7-4684-4525-994e-1e0ff90413d9	2025-05-08	Warnings	Exact identifier application number: M015
LANOZEM HEMORRHOIDAL	MENTHOL, PETROLATUM	Sod-e Biotech Ltd	34901e83-8f24-8460-e063-6394a90a2744	2025-05-07	Warnings	Exact identifier application number: M015
PREPARATION H	PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	96d2e0e7-2de0-4660-9ffd-9edb2ad224d8	2025-04-18	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42507-944-24	42507094424	1 TUBE in 1 CARTON (42507-944-24) / 51 g in 1 TUBE (42507-944-51)	1 tube	2008-08-11	No	No	Current