Lidocaine Viscous

Product NDC: 0121-0903
11-digit product format: 001210903
Labeler code: 0121
Product ID: 0121-0903_d5c843b5-65cb-b0a4-e053-2995a90a29e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Pharmaceutical Associates, Inc.
Application: ANDA088802
Marketing category: ANDA
Marketing start: 1985-04-26
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	0121-0903		D	Discontinued by firm		2026-08-10
excluded package	package	0121-0903	0121-0903-40	D	Discontinued by firm		2026-08-10

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0121-0903		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0121-0903	0121-0903-40	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A088802-001	LIDOCAINE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1985-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A088802-001	AT

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088802-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088802-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088802-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088802-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088802-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088802-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088802-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088802-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088802-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088802-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088802-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088802-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088802-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088802-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088802-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088802-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088802-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088802-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088802-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088802-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088802-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088802-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088802-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088802-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088802-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088802-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088802-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088802-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088802-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088802-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088802-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088802-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088802-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088802-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088802-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088802-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088802-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088802-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088802-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088802-001	AT	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0903-15	ML - Milliliter	0121-0903	d55405da-5e38-46af-a103-0367dd5b401f	1	2021-03-02
0121-0903-40	ML - Milliliter	0121-0903	44a296f4-184d-46d9-936d-3ca0e01cca3e	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0903	LIDOCAINE VISCOUS (LIDOCAINE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2	Legacy NDC	20220118_efb8bc14-26e8-4451-a40d-60bdfe4c605c.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Viscous	LIDOCAINE HYDROCHLORIDE	REMEDYREPACK INC.	6f8d20d2-6a91-4a5b-bfe8-f1baada38442	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088802 application number: ANDA088802
Lidocaine Viscous	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	79b42076-359d-4258-b1d8-f40e67ac5424	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088802 application number: ANDA088802
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0050d05a-b8e9-c544-e063-6294a90a0243	2024-02-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088802 application number: ANDA088802
Lidocaine Viscous	LIDOCAINE HYDROCHLORIDE	A-S Medication Solutions	75f2d450-aa2e-4a09-b4f7-4fcbcbf8b205	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088802 application number: ANDA088802

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0903-40	00121090340	4 TRAY in 1 CASE (0121-0903-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (0121-0903-15)	4 tray	2020-09-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)	Cardinal Health 107, LLC	2024-02-28	HUMAN PRESCRIPTION DRUG LABEL	3
Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)	Pharmaceutical Associates, Inc. \| West-Ward Columbus Inc.	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	2