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 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
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