Tetracaine

Product NDC: 71888-103
11-digit product format: 718880103
Labeler code: 71888
Product ID: 71888-103_47faba68-aab7-7eb8-e063-6294a90a3931
Type: HUMAN OTC DRUG
Nonproprietary name: Tetracaine
Dosage form: GEL
Route: TOPICAL
Labeler: Bellus Medical, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-06-01
Substance: TETRACAINE HYDROCHLORIDE
Active strength: 20 mg/1000mL
Pharmacologic classes: Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 12 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
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	71888-103-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	71888-103-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	71888-103-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	71888-103-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71888-103-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71888-103-02	`9bebd1f3094a…`	`5416666fcb17…`

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: Tetracaine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TETRACAINE HYDROCHLORIDE	20 mg/1000mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5NF5D4OPCI	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
60cabb5f-606b-7a74-e053-2a91aa0ac024	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a26f29b9-6919-4f09-a354-491df8d2b97d	Product name	1	20251021
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
122d1fa8-7b9e-49b4-89ce-b062ffd1d947	Product name	1	20181030
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-10-27	2% Tetracaine Gel
2023-10-27	2% Tetracaine Gel
2020-01-31	2% Tetracaine Gel
2020-01-31	2% Tetracaine Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71888-103-01	Tetracaine	4 mL in 1 PACKET	GEL	4		4
71888-103-02	Tetracaine	12 in 1 BOX	GEL	12		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71888-103	TETRACAINE GEL [BELLUS MEDICAL, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241120_60cabb5f-606b-7a74-e053-2a91aa0ac024.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 133 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HealthWise 3x Medicated Pain Relief Patch	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	164d4d62-00c0-e06d-e063-6294a90abd73	2024-04-17	Warnings	Exact identifier application number: M017
TIGER Balm PAIN RELIEVING HYDROGEL	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	ca601b02-e9be-4d8d-a384-c62553302ceb	2024-04-16	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	1592a40a-a647-34bd-e063-6394a90a0a10	2024-04-08	Warnings	Exact identifier application number: M017
Menticam	CAMPHOR, MENTHOL, METHYL SALICYLATE	PureTek Corporation	081837a8-9669-be1f-e063-6394a90a9d20	2024-04-05	Warnings	Exact identifier application number: M017
Pain Relieving Liniment	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	97a0c839-0927-4e54-aee2-ded2016ac4a0	2024-04-02	Warnings	Exact identifier application number: M017
HealthWise Capsaicin Heat Patch	CAPSAICIN	Veridian Healthcare	150c1f09-8aa7-67ea-e063-6294a90a950a	2024-04-01	Warnings	Exact identifier application number: M017
HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent	LIDOCAINE HCI	Veridian Healthcare	150d3e54-5c8d-19ef-e063-6394a90a70c2	2024-04-01	Warnings	Exact identifier application number: M017
Meijer Pain Relief Cream	LIDOCAINE	Meijer Distribution	07ecee44-387a-cdce-e063-6294a90ab9c9	2024-03-27	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	141aa2a7-8789-1127-e063-6294a90a2d23	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	1dc21c95-b419-4175-85f8-040b73060d37	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Roll-On Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	d94ae654-ce25-4bff-b9bd-24a0e0e8568a	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	f8bff018-fb4f-47b4-b8f8-4a496aede346	2024-03-20	Warnings	Exact identifier application number: M017
Rugby Arthritis Pain Relieving Topical Analgesic	CAPSAICIN	Rugby Laboratories	8f1bc075-97ac-4154-8768-0d878104c3ba	2024-03-14	Warnings	Exact identifier application number: M017
Rugby Ice Blue External Analgesic	MENTHOL, UNSPECIFIED FORM	Rugby Laboratories	2b65cb6a-4364-4770-b7b9-5c4637edd01a	2024-03-14	Warnings	Exact identifier application number: M017
Leader Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	fd06d17f-4dff-42a9-a84f-904809ceb981	2024-03-13	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	EROS GLOBAL	b3495c95-ba4b-9459-e053-2a95a90a710f	2024-03-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	1369e70f-7a61-7078-e063-6394a90a9a88	2024-03-11	Warnings	Exact identifier application number: M017
Pain Reliever Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	130665d6-3de8-cb91-e063-6294a90a2083	2024-03-06	Warnings	Exact identifier application number: M017
Dermachange Aid Anti-Itch	DIPHENHYDRAMINE HCL	Private Label Beauty and Wellness	12ed906c-d028-0ff7-e063-6394a90aaa52	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Cold Therapy	MENTHOL	Private Label Beauty and Wellness	12ef7dd8-3da3-9c87-e063-6394a90ac924	2024-03-05	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5NF5D4OPCI	TETRACAINE HYDROCHLORIDE	136-47-0	TETRACAINE HYDROCHLORIDE
0619F35CGV	TETRACAINE	94-24-6	Tetracaine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71888-103-01	71888010301	4 mL in 1 PACKET	4 ml				Historical
71888-103-02	71888010302	12 PACKET in 1 BOX (71888-103-02) / 4 mL in 1 PACKET (71888-103-01)	12 packet	2017-06-01	No	No	Current