Oraqix

Product NDC: 66312-110
11-digit product format: 663120110
Labeler code: 66312
Product ID: 66312-110_9cea1cd7-afdc-4ff7-a3a5-6133d15c1230
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lidocaine and prilocaine
Dosage form: GEL
Route: PERIODONTAL
Labeler: Dentsply Pharmaceutical
Application: NDA021451
Marketing category: NDA
Marketing start: 2004-01-02
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 42.

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
N021451-001	ORAQIX	LIDOCAINE; PRILOCAINE	2.5%;2.5%	GEL / PERIODONTAL		RLD, RS	2003-12-19

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021451-001	ORAQIX	2.5%;2.5%	GEL / PERIODONTAL	RLD, RS	2003-12-19	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oraqix
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897114	Internal RxNorm lookup
897117	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
b501d239-923b-48b2-82ed-6c5c253a67e2	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
66312-110-20	Oraqix	20 in 1 CARTON	GEL	20		12
66312-110-20	Oraqix	1 in 1 APPLICATOR	GEL	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66312-110-20	GM - Gram	66312-110	82f3b017-8c51-4f4a-a519-d8a8decb058c	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lidocaine	ACTIVE INGREDIENT	98PI200987	ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]	6
prilocaine	ACTIVE INGREDIENT	046O35D44R	ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]	6
lidocaine	ACTIVE MOIETY	98PI200987	ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]	6
prilocaine	ACTIVE MOIETY	046O35D44R	ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]	6
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]	6
poloxamer 188	INACTIVE INGREDIENT	LQA7B6G8JG	ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]	6
poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]	6
water	INACTIVE INGREDIENT	059QF0KO0R	ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66312-110	ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]	11	Current NDC, Legacy NDC, 2 package rows	20240127_b501d239-923b-48b2-82ed-6c5c253a67e2.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oraqix	LIDOCAINE AND PRILOCAINE	Dentsply Pharmaceutical	b501d239-923b-48b2-82ed-6c5c253a67e2	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021451 application number: NDA021451 ndc (product): 66312-110

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
897114	lidocaine 2.5 % / prilocaine 2.5 % Periodontal Gel	PSN	b501d239-923b-48b2-82ed-6c5c253a67e2	12
897117	oraqix 2.5 % / 2.5 % Periodontal Gel	PSN	b501d239-923b-48b2-82ed-6c5c253a67e2	12
897117	lidocaine 25 MG/ML / prilocaine 25 MG/ML Mucous Membrane Topical Solution [Oraqix]	SBD	b501d239-923b-48b2-82ed-6c5c253a67e2	12
897114	lidocaine 25 MG/ML / prilocaine 25 MG/ML Mucous Membrane Topical Solution	SCD	b501d239-923b-48b2-82ed-6c5c253a67e2	12
897114	lidocaine 2.5 % / prilocaine 2.5 % Oromucosal Solution	SY	b501d239-923b-48b2-82ed-6c5c253a67e2	12
897114	lidocaine 2.5 % / prilocaine 2.5 % Periodontal Gel	SY	b501d239-923b-48b2-82ed-6c5c253a67e2	12
897117	Oraqix 2.5 % / 2.5 % Periodontal Gel	SY	b501d239-923b-48b2-82ed-6c5c253a67e2	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66312-110-20	66312011020	20 APPLICATOR in 1 CARTON (66312-110-20) / 1 CARTRIDGE in 1 APPLICATOR / 1.7 g in 1 CARTRIDGE	20 applicator	2004-01-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oraqix	Dentsply Pharmaceutical \| Meribel Pharma Karlskoga AB	2026-04-21	HUMAN PRESCRIPTION DRUG LABEL	12