Topicaine Ultra

Product NDC: 85477-307
11-digit product format: 854770307
Labeler code: 85477
Product ID: 85477-307_39d5838a-c935-4447-a315-d27d91659444
Type: HUMAN OTC DRUG
Nonproprietary name: Topicaine Ultra
Dosage form: GEL
Route: TOPICAL
Labeler: Oncora Pharma, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-03-01
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 20 mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Topicaine Ultra
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1011852	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
e052f718-700a-44e0-8770-65451b812ee1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85477-307-85	Topicaine Ultra	85 g in 1 TUBE	GEL	85		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85477-307-85	GM - Gram	85477-307	7d824502-cb0c-41c3-bdc6-f180ed0563a0	1	2026-04-20

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 125 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terrasil Bruise and Pain Relief Maximum Strength	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	240b231d-a8b2-c64c-e063-6394a90a7440	2024-10-09	Warnings	Exact identifier application number: M017
Muscle Freeze Relief	MENTHOL	NATURAL ESSENTIALS, INC.	815c534b-096d-49f2-b5f2-8c885d45a5e6	2024-10-09	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	2410dc2f-9332-19fa-e063-6394a90a2835	2024-10-09	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain-Relieving	LIDOCAINE	Natural Essentials, Inc.	fc23b2e2-4abc-4119-b8bd-305b4327f1dd	2024-10-09	Warnings	Exact identifier application number: M017
KERACARE	MENTHOL 1%	Avlon Industries, Inc.	f72eec6d-1204-4e03-8aed-d5bcf8d3bbce	2024-10-09	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Eagle Indo Pharma, PT	da338796-de9c-be51-e053-2a95a90a2509	2024-10-07	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Eagle Indo Pharma	e2c5f821-cdd5-190d-e053-2a95a90a9159	2024-10-07	Warnings	Exact identifier application number: M017
NanoXtreme Pain Relieving	MENTHOL, METHYL SALICYLATE	MG Science Technologies LLC	c1490c30-a9db-4120-adaf-9e8000169e46	2024-10-07	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	ea656cf8-cad5-4fa5-82e7-daec77a0bb04	2024-10-07	Warnings	Exact identifier application number: M017
Eagle Medicated Oil Refreshing	MENTHOL, METHYL SALICYLATE	Eagle Indo Pharma, PT	e2729023-d689-7ae2-e053-2a95a90a78dc	2024-10-06	Warnings	Exact identifier application number: M017
Flanax Back Pain Relief	LIDOCAINE	Belmora LLC	46d33346-e582-4af1-b81a-feca7033dceb	2024-10-04	Warnings	Exact identifier application number: M017
Muscle Balm	MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)	Natural Essentials, Inc.	16918ba3-2e07-4232-9ed3-4c7751796cd2	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze Pain Relieving Continuous	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	998a4824-9ed9-4fe0-b45b-72e52861fcd3	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze Lidocaine Roll-On	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	Natural Essentials, Inc.	74b06366-5eb4-4eba-aa2b-2b672828294d	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze Lidocaine	LIDOCAINE	Natural Essentials, Inc.	029bd3fb-1b5b-48e0-b9af-d91d548b5b0f	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze	MENTHOL	Natural Essentials Inc.	a96e3e41-871c-4cf3-93b6-af2a6246ded8	2024-10-04	Warnings	Exact identifier application number: M017
CVS Pain Relief	MENTHOL 4%	CVS	20234356-5e80-b79e-e063-6294a90a2ee3	2024-10-04	Warnings	Exact identifier application number: M017
FLANAX BACK PAIN RELIEF	LIDOCAINE	Belmora Llc	af4bf57c-f250-4506-83eb-e0f253e96062	2024-10-04	Warnings	Exact identifier application number: M017
topcare hydrocortisone	HYDROCORTISONE	Topco Associates LLC	11a30ec9-ebc2-4a00-8a8d-431d0d973b37	2024-10-03	Warnings	Exact identifier application number: M017
pain relief patch	LIDOCAINE 4%	Bionpharma Inc.	19c69983-4e78-8ec5-e063-6394a90a84be	2024-10-03	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1011852	lidocaine HCl 2 % Topical Gel	PSN	e052f718-700a-44e0-8770-65451b812ee1	1
1011852	lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	e052f718-700a-44e0-8770-65451b812ee1	1
1011852	lidocaine hydrochloride 2 % Topical Jelly	SY	e052f718-700a-44e0-8770-65451b812ee1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85477-307-85	85477030785	85 g in 1 TUBE (85477-307-85)	85 g	2026-03-01	No	No	Current