DX1 OraGenomic Medicated DNA Collection Screen

Product NDC: 70529-441
Requested package NDC: 70529-441-01
11-digit product format: 705290441
Labeler code: 70529
Product ID: 70529-441_1b324ab5-3467-43d7-bf47-c8aebc7dccf2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: KIT
Labeler: IT3 Medical LLC
Application: ANDA040014
Marketing category: ANDA
Marketing start: 2016-05-01
Marketing end: 0000-00-00
Active strength: 0
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70529-441	70529-441-01	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A040014-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10

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	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`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	A040014-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040014-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040014-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040014-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040014-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040014-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040014-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040014-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040014-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040014-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040014-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040014-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040014-001	AT	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040014-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040014-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040014-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040014-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040014-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040014-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040014-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040014-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040014-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040014-001	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70529-441-01	2023-07-28	C162847	48780-1	d6a99b39-d33a-a426-e053-dadaa90af4c2	DX1 OraGenomic Medicated DNA Collection Screen
70529-441-01	2022-03-01	C162847	48780-1	d6a99b39-d33a-a426-e053-dadaa90af4c2	DX1 OraGenomic Medicated DNA Collection Screen
70529-441-01	2022-01-28	C162847	48780-1	d6a99b39-d33a-a426-e053-dadaa90af4c2	DX1 OraGenomic Medicated DNA Collection Screen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50383-775-15	DX1 OraGenomic Medicated DNA Collection Screen	15 mL in 1 CUP, UNIT-DOSE	SOLUTION	15 mL	20 mg in 1mL	4
63517-160-01	DX1 OraGenomic Medicated DNA Collection Screen	9 g in 1 PACKET	SWAB	9 g	7.5 g in 100g	4
68345-883-50	DX1 OraGenomic Medicated DNA Collection Screen	1.5 g in 1 PACKET	LIQUID	3 g	0.13 g in 100g	4
70529-441-01	DX1 OraGenomic Medicated DNA Collection Screen	1 in 1 PACKAGE	KIT	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70529-441-01	EA - Each	70529-441	e5b49cbe-d2e6-44b8-b0bb-51254ce8b95e	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70529-441	DX1 ORAGENOMIC MEDICATED DNA COLLECTION SCREEN (LIDOCAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC]	4	Legacy NDC, 4 package rows	20220302_802fe200-8aad-464c-84f7-74d1809c4dd8.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
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5a41d694-4628-4911-e053-2991aa0a91e5	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040014 application number: ANDA040014

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038558	benzalkonium chloride 0.13 % Medicated Pad	PSN	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1114098	glycerin 7.5 % Medicated Pad	PSN	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1010739	lidocaine HCl 2 % Mucous Membrane Topical Solution	PSN	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1038558	benzalkonium chloride 1.3 MG/ML Medicated Pad	SCD	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1114098	glycerin 75 MG/ML Medicated Pad	SCD	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1010739	lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical Solution	SCD	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1038558	benzalkonium chloride 0.13 % Topical Cloth	SY	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1038558	benzalkonium chloride 0.13 % Topical Swab	SY	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Pad	SY	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Swab	SY	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1038558	benzalkonium chloride 1 ML per 750 ML Topical Swab	SY	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1114098	glycerin 7.5 % Medicated Swab	SY	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1010739	lidocaine HCl 2 % Oral Topical Solution	SY	802fe200-8aad-464c-84f7-74d1809c4dd8	4
1010739	lidocaine HCl 2 % Oromucosal Solution	SY	802fe200-8aad-464c-84f7-74d1809c4dd8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70529-441-01	70529044101	1 KIT in 1 PACKAGE (70529-441-01) * 1.5 g in 1 PACKET (68345-883-50) * 9 g in 1 PACKET (63517-160-01) * 15 mL in 1 CUP, UNIT-DOSE (50383-775-15)	1 kit	2016-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DX1 OraGenomic Medicated DNA Collection Screen	IT3 Medical LLC	2022-02-25	HUMAN PRESCRIPTION DRUG LABEL	4