THE SOLUTION

Product NDC: 82617-101
11-digit product format: 826170101
Labeler code: 82617
Product ID: 82617-101_2b369998-00c4-fcb6-e063-6294a90af2eb
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE
Dosage form: SPRAY
Route: TOPICAL
Labeler: SCALP TECH INC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-04-01
Substance: LIDOCAINE HYDROCHLORIDE; EPINEPHRINE HYDROCHLORIDE
Active strength: 5; .01 g/100mL; g/100mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 4 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
2025-01-20 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	82617-101-14	`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	82617-101-14	`0efc9e666f02…`	`f202fb6c5f17…`

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: THE SOLUTION
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	5 g/100mL
EPINEPHRINE HYDROCHLORIDE	.01 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup
WBB047OO38	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2601579	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
df51623c-e0b6-8e86-e053-2995a90a59b2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82617-101-14	THE SOLUTION	118 mL in 1 BOTTLE, SPRAY	SPRAY	118		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82617-101	THE SOLUTION (LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE) SPRAY [SCALP TECH INC]	4	Current NDC, Legacy NDC, 1 package rows	20250122_df51623c-e0b6-8e86-e053-2995a90a59b2.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 22 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family wellness	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	FRONT PHARMACEUTICAL PLC	cfdd61e3-e12e-491c-b2a8-90fae19e8870	2023-10-27	Warnings	Exact identifier application number: M015
Family Wellness	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUM	FRONT PHARMACEUTICAL PLC	eb1785f4-5876-443b-b175-9b59d65d1a48	2023-10-26	Warnings	Exact identifier application number: M015
CVS Health Hemorrhoidal Cream	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	FRONT PHARMACEUTICAL PLC	cb448d78-553c-4e65-80c5-d4b31d7b3661	2023-10-26	Warnings	Exact identifier application number: M015
Family Wellness	PHENYLEPHRINE HCL, PETROLATUM, MINERAL	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bfa195d7-d87f-43b5-bbf1-7ec3a451de05	2023-10-25	Warnings	Exact identifier application number: M015
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots	LIDOCAINE	CVS PHARMACY, INC	82aa128a-44cd-4907-b0f7-8a31e086d3e6	2023-10-25	Warnings	Exact identifier application number: M015
TheraPlus Plus	PHENYLEPHRINE HCI	Zhejiang Jingwei Pharmaceutical Co., Ltd.	edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d	2023-10-25	Warnings	Exact identifier application number: M015
Assured Bikini Smooth Cream	LIDOCAINE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fb9ddde3-3f40-467e-8aff-26570144f0fc	2023-10-25	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM	Cardinal Health 110, LLC. dba Leader	85a51d5c-679e-1959-e053-2a91aa0a76d5	2023-10-25	Warnings	Exact identifier application number: M015
Family Wellness	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fde9cd90-d63c-4058-b46e-511fecea36ec	2023-10-24	Warnings	Exact identifier application number: M015
Lidocaine 5%	LIDOCAINE	Apnar Pharma LP	ceedce20-5723-5a9a-e053-2a95a90a17a1	2023-10-21	Warnings	Exact identifier application number: M015
Numquick Topical Analgesic	EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE	Unit Dose, Ltd.	3f64cbd3-6745-4397-9767-3adc3b301e0e	2023-10-19	Warnings	Exact identifier application number: M015
Healquick Tattoo Balm	PETROLATUM	Unit Dose, Ltd.	96f92c82-a79a-4d7e-ba0c-5ea67e2b6e86	2023-10-19	Warnings	Exact identifier application number: M015
Numpot Topical Anesthetic	LIDOCAINE, PETROLATUM	Unit Dose, Ltd.	9143b50b-7d76-4545-aa2e-1bb77ffb44ae	2023-10-19	Warnings	Exact identifier application number: M015
Microcaine Topical Analgesic	LIDOCAINE	Unit Dose, Ltd.	5e8fa8b5-0524-4201-91e1-83e59a8f0415	2023-10-19	Warnings	Exact identifier application number: M015
Numstick	PETROLATUM, LIDOCAINE	Unit Dose, Ltd.	127bbd87-5402-4da2-abf3-dac6367735ec	2023-10-18	Warnings	Exact identifier application number: M015
ADVANCED NUMB Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	Uber Scientific, LLC	859d1cad-badf-4c42-9b08-daacb3fae8b4	2023-10-13	Warnings	Exact identifier application number: M015
Hemorrhoidal Pain Relief with Aloe and VitaminE	HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE	NeilMed pharmaceuticals Inc.	076b5021-8ba0-0204-e063-6294a90a3337	2023-10-11	Warnings	Exact identifier application number: M015
Zensa Numbing Gel	LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Alera Skin Care Products Inc.	065a6eec-3896-0da8-e063-6394a90a849d	2023-09-27	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE
WBB047OO38	EPINEPHRINE HYDROCHLORIDE	55-31-2	EPINEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2601579	EPINEPHrine HCl 0.01 % / lidocaine HCl 5 % Rectal Spray	PSN	df51623c-e0b6-8e86-e053-2995a90a59b2	4
2601579	epinephrine hydrochloride 0.1 MG/ML / lidocaine hydrochloride 50 MG/ML Rectal Spray	SCD	df51623c-e0b6-8e86-e053-2995a90a59b2	4
2601579	epinephrine hydrochloride 0.01 % / lidocaine hydrochloride 5 % Rectal Spray	SY	df51623c-e0b6-8e86-e053-2995a90a59b2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82617-101-14	82617010114	118 mL in 1 BOTTLE, SPRAY (82617-101-14)	118 ml	2022-04-01	0000-00-00	No	No	Current