IQ Dental Mepivacaine

Product NDC: 42756-1080
11-digit product format: 427561080
Labeler code: 42756
Product ID: 42756-1080_2cb0fd05-0e79-42d4-b5d3-caaab9e4f625
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mepivacaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: IQ Dental
Application: ANDA088387
Marketing category: ANDA
Marketing start: 2012-08-15
Marketing end: 0000-00-00
Substance: MEPIVACAINE HYDROCHLORIDE
Active strength: 30 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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	42756-1080		D	Discontinued by firm		2026-08-07
excluded package	package	42756-1080	42756-1080-5	D	Discontinued by firm		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088387-001	SCANDONEST PLAIN	MEPIVACAINE HYDROCHLORIDE	3%	INJECTABLE / INJECTION		RS	1984-10-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088387-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088387-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088387-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088387-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088387-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088387-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088387-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088387-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088387-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088387-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088387-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088387-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088387-001	AP	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A088387-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088387-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088387-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088387-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088387-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088387-001	AP	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mepivacaine Hydrochloride	ACTIVE INGREDIENT	4VFX2L7EM5	IQ DENTAL MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [IQ DENTAL]	1
Mepivacaine	ACTIVE MOIETY	B6E06QE59J	IQ DENTAL MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [IQ DENTAL]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	IQ DENTAL MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [IQ DENTAL]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	IQ DENTAL MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [IQ DENTAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42756-1080	IQ DENTAL MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [IQ DENTAL]	6	Legacy NDC	20240223_5ad26708-14fe-4d31-91df-fa6813bdde7c.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 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Scandonest 3% Plain	MEPIVACAINE HYDROCHLORIDE	Septodont, Inc.	af6ff5f6-7221-421b-9b7c-8fcee4a47772	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
MEPIVACAINE HYDROCHLORIDE	MEPIVACAINE HYDROCHLORIDE	Safco Dental Supply Co.	c4d45717-86c9-45bf-ba8e-2c255814ab50	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Novocol Pharmaceutical of Canada, Inc.	f58cb2c7-22a6-4341-8f9a-85c5628af797	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Darby Dental Supply, LLC	5e81dae6-e55b-4d5e-9318-1d9395db052e	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Mepivacaine Hydrochloride	MEPIVACAINE HYDROCHLORIDE	Henry Schein Inc.	a3c2cddc-827b-4644-9060-e2fd2188b459	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Carbocaine	MEPIVACAINE HYDROCHLORIDE	Septodont, Inc.	1f2f9e40-e437-4124-97b7-df67dbafd154	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Polocaine	MEPIVACAINE HYDROCHLORIDE	Novocol Pharmaceutical of Canada Inc.	eb7e2284-fe8d-46ad-b1d3-92ee2c6222bf	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Benco Dental	c9a5a849-d010-4637-a66a-c26176401fbd	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	NDC, Inc.	042010fb-7161-4336-b91f-5a25839ee644	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Patterson Dental Supply, Inc.	e8a3df4b-e918-4813-af3e-3c95f2c54250	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Polocaine	MEPIVACAINE HYDROCHLORIDE	Dentsply Pharmaceutical	25074a6a-7f67-4ad8-86e0-2afe23ec5d04	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4VFX2L7EM5	MEPIVACAINE HYDROCHLORIDE	1722-62-9	MEPIVACAINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42756-1080-5	42756108005	50 CARTRIDGE in 1 CARTON (42756-1080-5) > 1.7 mL in 1 CARTRIDGE	50 cartridge	2012-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mepivacaine HCl 3% (30 mg/mL) (Mepivacaine Hydrochloride Injection, USP)	IQ Dental \| Novocol Pharmaceutical of Canada, Inc.	2024-02-21	HUMAN PRESCRIPTION DRUG LABEL	6