Treatonic hemorrhoid treatment

Product NDC: 85569-008
11-digit product format: 855690008
Labeler code: 85569
Product ID: 85569-008_58db951c-2398-4a7c-e063-6394a90a02c6
Type: HUMAN OTC DRUG
Nonproprietary name: 5% lidocaine
Dosage form: CREAM
Route: TOPICAL
Labeler: 100 KARMA INC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-10-31
Substance: LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 2.5; .125 g/50g; g/50g
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: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	85569-008		D	Discontinued by firm		2026-10-12
excluded package	package	85569-008	85569-008-01	D	Discontinued by firm		2026-10-12

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	85569-008		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	85569-008	85569-008-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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: Treatonic hemorrhoid treatment
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	2.5 g/50g
PHENYLEPHRINE HYDROCHLORIDE	.125 g/50g

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
1314136	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
41442fa7-c511-07ca-e063-6294a90a3992	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
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	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
85569-008-01	Treatonic hemorrhoid treatment	50 g in 1 CARTON	CREAM	50		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 16 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calmoseptine	ANORECTAL OINTMENT	Calmoseptine Inc.	ff9539ed-d9ae-401d-adbc-df8f1d751431	2025-01-13	Warnings	Exact identifier application number: M015
Dibucaine	DIBUCAINE	Akron Pharma Inc.	60469e43-ab6f-46d3-a1df-00e58275f565	2025-01-12	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Chain Drug Marketing Association Inc.	2b490a08-149d-76ab-e063-6394a90a084f	2025-01-09	Warnings	Exact identifier application number: M015
Drs. pharmacy HEMORRHOIDAL COOLING	PHENYLEPHRINE HCL, WITCH HAZEL	OL PHARMA TECH, LLC Drs PHARMACY	d6f6b482-d85d-001c-e053-2995a90ad98c	2025-01-09	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream with Aloe	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Chain Drug Marketing Association	2b33c710-ac17-20f9-e063-6294a90ad29c	2025-01-08	Warnings	Exact identifier application number: M015
THE SOLUTION	LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE	SCALP TECH INC	df51623c-e0b6-8e86-e053-2995a90a59b2	2025-01-08	Warnings	Exact identifier application number: M015
frida mom Perineal Cooling Pad Liners	WITCH HAZEL	Fridababy, LLC	a461ff3d-e115-4f15-a545-bacb502ff6cd	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Postpartum Recovery Essentials	WITCH HAZEL	Fridababy, LLC	2d26c6f2-5d31-4c07-9f40-2fbfcfbf1234	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Perineal Healing	WITCH HAZEL	Fridababy, LLC	6a58e2a8-c4d5-4078-b5f4-28504de1f020	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Labor and Delivery Plus Postpartum Recovery	WITCH HAZEL	Fridababy, LLC	4b5fc312-4c8c-4396-a70c-b1ed129038c7	2024-12-30	Warnings	Exact identifier application number: M015
Tucks Triple Relief Hemorrhoidal	WHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Blistex Inc.	bf892e90-2d9b-4fa0-8ee4-8a2736be6c30	2024-12-24	Warnings	Exact identifier application number: M015
BLISS GVS HEMORRHOIDAL	PHENYLEPHRINE HCL	Bliss GVS Pharma Limited	fceea303-2ea0-10e9-e053-6294a90a5492	2024-12-21	Warnings	Exact identifier application number: M015
Dibucaine	DIBUCAINE 1%	Geri-Care Pharmaceuticals, Corp	afe88610-5cac-960e-e053-2a95a90a7ba4	2024-12-20	Warnings	Exact identifier application number: M015
Hemorroidal Cooling gel	PHENYLEPHRINE, WITCH HAZEL	Pharmacy Value Alliance, LLC	7276aab8-0297-2a55-e053-2a91aa0a8d21	2024-12-20	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Pharmacy Value Alliance, LLC	3803a61b-308a-14a9-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M015
Bliss GVS Hemorrhoidal	HARD FAT, PHENYLEPHRINE HCL	Bliss GVS Pharma Limited	88c49f6c-2a48-2dae-e053-2a95a90af20a	2024-12-19	Warnings	Exact identifier application number: M015
Rectal Care Cream Revivol	LIDOCAINE 5%	Derma Care Research Labs	a1c75161-f84a-e996-e053-2a95a90ac0c5	2024-12-19	Warnings	Exact identifier application number: M015
DCH Numbing Relief	LIDOCAINE 5%	Derma Care Research Labs, LLC	ffd70a31-7d0c-d2d0-e053-6394a90a8674	2024-12-19	Warnings	Exact identifier application number: M015
DCH Hemorrhoidal	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Derma Care Research Labs, LLC	0050701f-4393-3f01-e063-6394a90a4e0e	2024-12-19	Warnings	Exact identifier application number: M015
Moshe Numbing Hemorrhoidal	LIDOCAINE 5%	Derma Care Research Labs	fbd5b488-1921-e9b7-e053-6294a90aba70	2024-12-19	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
1314136	lidocaine 5 % / phenylephrine HCl 0.25 % Rectal Cream	PSN	41442fa7-c511-07ca-e063-6294a90a3992	1
1314136	lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream	SCD	41442fa7-c511-07ca-e063-6294a90a3992	1
1314136	lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Cream	SY	41442fa7-c511-07ca-e063-6294a90a3992	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85569-008-01	85569000801	50 g in 1 CARTON (85569-008-01)	50 g	2025-10-31	No	No	Current