LIDOCAINE AND PRILOCAINE

Product NDC: 50090-6589
11-digit product format: 500906589
Labeler code: 50090
Product ID: 50090-6589_8805f391-a4c9-4399-ab71-9198128e27a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine and Prilocaine
Dosage form: CREAM
Route: TOPICAL
Labeler: A-S Medication Solutions
Application: ANDA212482
Marketing category: ANDA
Marketing start: 2022-12-20
Substance: LIDOCAINE; PRILOCAINE
Active strength: 25; 25 mg/g; mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212482-001	LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB		2021-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212482-001	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212482-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212482-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212482-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212482-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212482-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212482-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212482-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212482-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212482-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212482-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212482-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212482-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212482-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212482-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212482-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212482-001	AB	1	`8072bd15b7f6…`
2021-12-28 21:50 UTC	2021-12	A212482-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212482-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212482-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212482-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212482-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212482-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212482-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212482-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212482-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212482-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212482-001	AB	1	`a50c72e98297…`

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: LIDOCAINE AND PRILOCAINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	25 mg/g
PRILOCAINE	25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98PI200987	Internal UNII lookup
046O35D44R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197877	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
a4c310f5-e83e-4e40-a73d-818da5f49fec	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6589-0	LIDOCAINE AND PRILOCAINE	30 g in 1 TUBE	CREAM	30		1
50090-6589-0	LIDOCAINE AND PRILOCAINE	1 in 1 CARTON	CREAM	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6589-0	GM - Gram	50090-6589	662c58fe-2bc4-4d0a-a6df-a69e98d91acf	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6589	LIDOCAINE AND PRILOCAINE CREAM [A-S MEDICATION SOLUTIONS]	1	Current NDC, 2 package rows	20230818_a4c310f5-e83e-4e40-a73d-818da5f49fec.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Padagis US LLC	6e1635f7-dcae-441b-bbf7-495661fb66ae	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Preferred Pharmaceuticals Inc.	82111bef-460f-4948-a19c-1d2063427ee4	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Bryant Ranch Prepack	3cd9a055-8b9b-4dff-967b-54023df72e43	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Bryant Ranch Prepack	889a8ba8-4058-49e1-8b28-08a3afbf280f	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Bryant Ranch Prepack	5bee9fab-a493-448e-b68c-fb58156d49b6	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	NuCare Pharmaceuticals, Inc.	365e59a2-b970-2ab1-e063-6294a90acfa9	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Bryant Ranch Prepack	2cd9f2a5-3726-4c74-b561-1555faf8ea88	2024-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	A-S Medication Solutions	a4c310f5-e83e-4e40-a73d-818da5f49fec	2023-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482 ndc (product): 50090-6589

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE
046O35D44R	PRILOCAINE	721-50-6	PRILOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197877	lidocaine 2.5 % / prilocaine 2.5 % Topical Cream	PSN	a4c310f5-e83e-4e40-a73d-818da5f49fec	1
197877	lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream	SCD	a4c310f5-e83e-4e40-a73d-818da5f49fec	1
197877	lidocaine 2.5 % / prilocaine 2.5 % Topical Cream	SY	a4c310f5-e83e-4e40-a73d-818da5f49fec	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-6589-0	50090658900	1 TUBE in 1 CARTON (50090-6589-0) / 30 g in 1 TUBE	1 tube	2023-08-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine and Prilocaine Cream USP, 2.5%/2.5%	A-S Medication Solutions	2023-08-17	HUMAN PRESCRIPTION DRUG LABEL	1