Dr Butlers Hemorrhoid and Fissure PF

Product NDC: 70942-357
Requested package NDC: 70942-357-01
11-digit product format: 709420357
Labeler code: 70942
Product ID: 70942-357_44848a07-eb1f-3040-e063-6294a90a1762
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocaine 4.00, Phenylephrine Hydrochloride 0.25
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Beyond Health P.A.
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-02-20
Substance: LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 4; .25 g/100g; g/100g
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], 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: Dr Butlers Hemorrhoid and Fissure PF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	4 g/100g
PHENYLEPHRINE HYDROCHLORIDE	.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98PI200987	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
2673304	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
f526199e-5c9e-7a3c-e053-2a95a90aa98e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70942-357-00	Dr Butlers Hemorrhoid and Fissure PF	28 g in 1 TUBE	OINTMENT	28	5
70942-357-01	Dr Butlers Hemorrhoid and Fissure PF	1 in 1 CARTON	OINTMENT	1	5
70942-357-05	Dr Butlers Hemorrhoid and Fissure PF	42.5 g in 1 TUBE	OINTMENT	42.5	5
70942-357-06	Dr Butlers Hemorrhoid and Fissure PF	2 g in 1 PACKET	OINTMENT	2	5
70942-357-07	Dr Butlers Hemorrhoid and Fissure PF	21.3 g in 1 TUBE	OINTMENT	21.3	5
70942-357-12	Dr Butlers Hemorrhoid and Fissure PF	12 in 1 CARTON	OINTMENT	12	5
70942-357-15	Dr Butlers Hemorrhoid and Fissure PF	1 in 1 CARTON	OINTMENT	1	5
70942-357-75	Dr Butlers Hemorrhoid and Fissure PF	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
70942-357-07	GM - Gram	70942-357	33bcdb8c-dc7c-460c-88a9-a08b3eb6ecfc	1	2025-11-13
70942-357-75	GM - Gram	70942-357	3b213a17-51e1-483f-ad34-8d8d9712ebff	1	2025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70942-357	DR BUTLERS HEMORRHOID AND FISSURE PF (LIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25) OINTMENT [BEYOND HEALTH P.A.]	2	Current NDC, 8 package rows	20241217_f526199e-5c9e-7a3c-e053-2a95a90aa98e.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 19 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Meijer Distribution Inc	14319ba4-3bce-497c-a380-65bd24defc5d	2024-10-17	Warnings	Exact identifier application number: M015
equate hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	581dd76f-d052-4448-8139-9a2e31891b25	2024-10-17	Warnings	Exact identifier application number: M015
Equate Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	81ecb091-38da-4b3e-a0a1-b4986b97ee09	2024-10-16	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Kroger Company	5c81d564-f786-46e1-af8b-f47521fbae60	2024-10-16	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Topco Associates LLC	615e87e4-79e0-44d6-b563-3bcd5a9b2d93	2024-10-16	Warnings	Exact identifier application number: M015
Basic Care Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Amazon.com Services LLC	fe675174-fc95-4dd7-bd39-c209c6ce0f6c	2024-10-16	Warnings	Exact identifier application number: M015
hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Meijer Distribution Inc	fb170371-2e5d-43ca-a259-538a973ee3b8	2024-10-15	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Topco Associates LLC	5e13da07-48cf-40bc-bb11-fd891886cbea	2024-10-14	Warnings	Exact identifier application number: M015
hemorrhoidal maximum strength pain relief	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Kroger Company	3c8f90e2-fecf-4439-9faa-81a32ffe4753	2024-09-26	Warnings	Exact identifier application number: M015
equate hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Wal-Mart Stores Inc	5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d	2024-09-26	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal Pain Relief	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Walgreens	e79ed7ae-0d06-2f88-e053-2995a90a1e35	2024-09-20	Warnings	Exact identifier application number: M015
hemorrhoidal relief	COCOA BUTTER, PHENYLEPHRINE HCL	Rite Aid Corporation	ddafbdca-32c2-49c1-83d3-35b4155958c9	2024-08-15	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Rite Aid Corporation	8e1f223a-a3a0-4837-9847-2a3939fcc595	2024-08-15	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Bryant Ranch Prepack	485fd02f-bfea-41d0-90a1-f12fcfeb2a15	2024-08-14	Warnings	Exact identifier application number: M015
Up and Up Hemorrhoid MAX STRENGTH	14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUM	Target Corporation	867677b5-fd1d-449e-966e-1de0b5c98afb	2024-08-08	Warnings	Exact identifier application number: M015
Soothing Hemorrhoidal Wipes 50 Witch Hazel	WITCH HAZEL	The Honey Pot Company LLC	1ea202f5-e228-b3f2-e063-6294a90a16c1	2024-08-01	Warnings	Exact identifier application number: M015
Bunnies Bum Hemorrhoidal Numbing	LIDOCAINE	FloCal Distributors LLC	1c809643-0cbe-568f-e063-6394a90a3210	2024-07-05	Warnings	Exact identifier application number: M015
Bunnies Bum Soothing Hemorrhoidal	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	FloCal Distributors LLC	1c81582c-7ece-182f-e063-6294a90a8fbc	2024-07-05	Warnings	Exact identifier application number: M015
MegaBabe Butt Stuff Hemorrhoidal	COCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	MEGABABE, LLC	01c156ff-69f9-4d5e-a9ea-abbc52d4afff	2024-06-12	Warnings	Exact identifier application number: M015
PUREGEN LABS Maximum Strength Lidocaine	LIDOCAINE	Advanced Rx LLC	f4f89582-49e6-424a-bea7-0694484a7c99	2024-04-11	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2673304	lidocaine 4 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	f526199e-5c9e-7a3c-e053-2a95a90aa98e	5
2673304	lidocaine 0.04 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	f526199e-5c9e-7a3c-e053-2a95a90aa98e	5
2673304	lidocaine 4 % / phenylephrine HCl 0.25 % Rectal Ointment	SY	f526199e-5c9e-7a3c-e053-2a95a90aa98e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70942-357-01	70942035701	1 TUBE in 1 CARTON (70942-357-01) / 28 g in 1 TUBE (70942-357-00)	1 tube	2023-02-20	No	No	Current