Claritin-D

Product NDC: 70518-3566
11-digit product format: 705183566
Labeler code: 70518
Product ID: 70518-3566_ec6ba057-440a-6a55-e053-2a95a90a6434
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine and pseudoephedrine sulfate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA019670
Marketing category: NDA
Marketing start: 2022-10-31
Marketing end: 0000-00-00
Substance: LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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	70518-3566		D	Discontinued by firm		2026-08-03
excluded package	package	70518-3566	70518-3566-0	D	Discontinued by firm		2026-08-03

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3566-0	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3566-0	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-3566-0	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-3566-0	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-3566-0	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-3566-0	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-3566-0	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-3566-0	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-3566-0	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-3566-0	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-3566-0	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-3566-0	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70518-3566-0	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70518-3566-0	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70518-3566-0	I	Inactivated by FDA	`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
N019670-002	CLARITIN-D	LORATADINE; PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2002-11-27

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3566-0	2024-10-09	C162847	48780-1	1030e365-0995-111a-e063-dadaa90a10e2	Claritin-D ® 12 Hour
70518-3566-0	2024-01-30	C162847	48780-1	1030e365-0995-111a-e063-dadaa90a10e2	Claritin-D ® 12 Hour

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
Claritin-D 12 Hour	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Bayer HealthCare LLC.	a7125705-01ff-4418-8c53-9209c2bbb484	2025-12-05	Warnings	Exact identifier application applno (NDA): 019670 application number: NDA019670

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE
Y9DL7QPE6B	PSEUDOEPHEDRINE SULFATE	7460-12-0	PSEUDOEPHEDRINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3566-0	70518356600	2 BLISTER PACK in 1 CARTON (70518-3566-0) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2022-10-31	0000-00-00	No	No	Current