Lidocaine and prilocaine

Product NDC: 50090-8089
11-digit product format: 500908089
Labeler code: 50090
Product ID: 50090-8089_7c1a8eb3-ca51-4f1a-a8a0-53a0e8cc2e16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine and prilocaine
Dosage form: CREAM
Route: TOPICAL
Labeler: A-S Medication Solutions
Application: ANDA219120
Marketing category: ANDA
Marketing start: 2025-01-01
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: 2027-12-31
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
A219120-001	LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB		2024-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219120-001	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	A219120-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2024-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219120-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2024-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219120-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2024-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219120-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2024-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219120-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2024-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219120-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2024-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219120-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2024-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A219120-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2024-12-17	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219120-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2024-12-17	`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	A219120-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219120-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219120-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219120-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219120-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219120-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219120-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A219120-001	AB	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219120-001	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: 2027-12-31

Active Ingredients#

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine and prilocaine	LIDOCAINE AND PRILOCAINE	Viona Pharmaceuticals Inc	0a3b26d3-7a32-4403-88ab-0924356b5214	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219120 application number: ANDA219120
Lidocaine and prilocaine	LIDOCAINE AND PRILOCAINE	Zydus Lifesciences Limited	f85ec4ed-4a1b-4680-ace1-b2a0b1114af5	2024-12-30		Exact identifier application applno (ANDA): 219120 application number: ANDA219120

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-8089-0	50090808900	1 TUBE in 1 CARTON (50090-8089-0) / 30 g in 1 TUBE	1 tube	2026-09-23	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	2026-09-25	HUMAN PRESCRIPTION DRUG LABEL	1