LORTUSS LQ

Product NDC: 70868-750
Requested package NDC: 70868-750-16
11-digit product format: 708680750
Labeler code: 70868
Product ID: 70868-750_d67cf0cc-7c66-8640-e053-2995a90a7b1e
Type: HUMAN OTC DRUG
Nonproprietary name: Doxylamine Succinate, Pseudoephedrine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: Key Therapeutics
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-05-15
Marketing end: 0000-00-00
Substance: DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 6 mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70868-750	70868-750-16	I	Inactivated by FDA		2026-10-15

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70868-750-16	2023-07-28	C162847	48780-1	d6a99b39-3d85-a426-e053-dadaa90af4c2	Lortuss LQ
70868-750-16	2022-02-04	C162847	48780-1	d6a99b39-3d85-a426-e053-dadaa90af4c2	Lortuss LQ
70868-750-16	2022-01-28	C162847	48780-1	d6a99b39-3d85-a426-e053-dadaa90af4c2	Lortuss LQ

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70868-750-16	LORTUSS LQ	473 mL in 1 BOTTLE	LIQUID	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70868-750-16	ML - Milliliter	70868-750	3c462e62-cdeb-4680-99af-82a94d00e350	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70868-750	LORTUSS LQ (DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KEY THERAPEUTICS]	2	Legacy NDC, 1 package rows	20220205_75eb63ff-88fd-450d-82d7-c91165929568.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1094355	doxylamine succinate 6.25 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	75eb63ff-88fd-450d-82d7-c91165929568	2
1094355	doxylamine succinate 1.25 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	75eb63ff-88fd-450d-82d7-c91165929568	2
1094355	doxylamine succinate 6.25 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution	SY	75eb63ff-88fd-450d-82d7-c91165929568	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70868-750-16	70868075016	473 mL in 1 BOTTLE (70868-750-16)	473 ml	2020-05-15	0000-00-00	No	No	Current