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 138 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cool n Heat	COOL N HEAT	NeilMed Pharmaceuticals, Inc.	a24cde17-280b-8358-e053-2a95a90af67d	2024-01-11	Warnings	Exact identifier application number: M017
NeilMed Anti-Itch	ANTI-ITCH SPRAY	NeilMed Pharmaceuticals Inc.	b3d34d9e-85d9-df4e-e053-2a95a90ac8d9	2024-01-11	Warnings	Exact identifier application number: M017
NeilMed Hot and Cold Pain Relief	PAIN RELIEF SPRAY	NeilMed Pharmaceuticals Inc.	b3d02111-7499-c2d4-e053-2a95a90ae1de	2024-01-11	Warnings	Exact identifier application number: M017
Cooling Itch Relief	COOLING ITCH RELIEF	NeilMed Pharmaceuticals, Inc	a24bdea0-18e8-8a5e-e053-2995a90acea2	2024-01-11	Warnings	Exact identifier application number: M017
Lightning X Burn	LIDOCAINE	Nantong Health & Beyond Hygienic Products Inc.	0e69a971-0c6e-6ebe-e063-6394a90a0b33	2024-01-08	Warnings	Exact identifier application number: M017
Theraworx Pain Relief Roll-On with Lidocaine for Diabetics	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29	2024-01-08	Warnings	Exact identifier application number: M017
2nd CHANCE MOBILITY Pain Relief	HISTAMINE DIHYDROCHLORIDE	ALPHA NUTRITION, LLC	575097ac-9fc9-4391-99d1-dff9b34817e3	2024-01-08	Warnings	Exact identifier application number: M017
Tiger Balm Arthritis Rub	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Haw Par Healthcare Ltd.	80932288-4797-40d3-aa8a-6af686fb67ad	2024-01-08	Warnings	Exact identifier application number: M017
OPRAVA	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Biological M.D. Solutions LLC	05552560-e283-5eba-e063-6294a90a65f7	2024-01-06	Warnings	Exact identifier application number: M017
MED O-3 BIO-	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Biological M.D. Solutions LLC	02707552-03d9-3ad2-e063-6294a90a3472	2024-01-06	Warnings	Exact identifier application number: M017
Sumifun Knee Relieving Patch	KNEE RELIEVING PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e7e73ec-ab33-9235-e063-6394a90ad950	2024-01-06	Warnings	Exact identifier application number: M017
Lidocaine Numbing Cream	LIDOCAINE	YYBA Corp	de6dc194-c6ef-4cb5-be3f-e772ace9abaf	2024-01-03	Warnings	Exact identifier application number: M017
Equate Vagicaine	20% BENZOCAINE AND 3% RESORCINOL CREAM	Walmart Inc.	0cdc9323-f5c3-468c-a7ae-83dfd2d76626	2024-01-03	Warnings	Exact identifier application number: M017
OWELL NATURALS Deep Penetrating Pain Relief	MENTHOL	OWELL NATURALS BRAND, LLC	b36eb017-ed8d-476e-994b-22b275e00543	2024-01-02	Warnings	Exact identifier application number: M017
Dibucaine	DIBUCAINE 1%	Trifecta Pharmaceuticals USA LLC	e8a56651-a292-7609-e053-2a95a90a7c36	2024-01-02	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	44d17651-a31b-64ca-e054-00144ff8d46c	2024-01-02	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	e0a13344-5493-eb51-e053-2995a90a8183	2024-01-02	Warnings	Exact identifier application number: M017
Sumifun Knee Relieve Patch	KNEE RELIEVE PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e031aa5-edf4-8c9d-e063-6394a90afee3	2024-01-02	Warnings	Exact identifier application number: M017
OKeeffes Healthy Feet	ALLANTOIN, LIDOCAINE	The Gorilla Glue Company/O'Keeffe's Company	d73709db-3932-3c56-e053-2995a90a7d0a	2024-01-01	Warnings	Exact identifier application number: M017
PERSONAL CARE ICE COLD	MENTHOL	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	1994356c-e347-5b7d-e063-6394a90a476c	2024-01-01	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