ATUSS DA

Product NDC: 58407-252
Requested package NDC: 58407-252-04
11-digit product format: 584070252
Labeler code: 58407
Product ID: 58407-252_cfd483f8-67e5-5ad7-e053-2995a90a8bd5
Type: HUMAN OTC DRUG
Nonproprietary name: Brompheniramine Maleate, Chlophedianol Hydrochloride, Pseudoephedrine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: Magna Pharmceuticals, Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2018-11-20
Marketing end: 0000-00-00
Substance: BROMPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 2 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	58407-252	58407-252-04	I	Inactivated by FDA		2026-10-05

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 · 16 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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
58407-252-01	2022-07-29	C162847	48780-1	e4f33bdf-b061-d8a0-e053-dadaa90a6e4e	ATUSS DA
58407-252-04	2022-07-29	C162847	48780-1	e4f33bdf-b061-d8a0-e053-dadaa90a6e4e	ATUSS DA
58407-252-16	2022-07-29	C162847	48780-1	e4f33bdf-b061-d8a0-e053-dadaa90a6e4e	ATUSS DA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58407-252-01	ATUSS DA	15 mL in 1 BOTTLE	LIQUID	15	4
58407-252-01	ATUSS DA	6 in 1 CARTON	LIQUID	6	4
58407-252-04	ATUSS DA	118 mL in 1 BOTTLE	LIQUID	118	4
58407-252-16	ATUSS DA	473 mL in 1 BOTTLE	LIQUID	473	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58407-252-04	ML - Milliliter	58407-252	0db69bfc-d992-495c-99f5-692ab6da2544	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58407-252	ATUSS DA (BROMPHENIRAMINE MALEATE, CHLOPHEDIANOL HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MAGNA PHARMCEUTICALS, INC.]	4	Legacy NDC, 4 package rows	20211103_7ba8db45-f5b6-5d32-e053-2991aa0a77b7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IXA7C9ZN03	BROMPHENIRAMINE MALEATE	980-71-2	BROMPHENIRAMINE MALEATE
69QQ58998Y	CHLOPHEDIANOL HYDROCHLORIDE	511-13-7	CHLOPHEDIANOL HYDROCHLORIDE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1014331	brompheniramine maleate 2 MG / chlophedianol HCl 12.5 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	7ba8db45-f5b6-5d32-e053-2991aa0a77b7	4
1014331	brompheniramine maleate 0.4 MG/ML / chlophedianol hydrochloride 2.5 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	7ba8db45-f5b6-5d32-e053-2991aa0a77b7	4
1014331	brompheniramine maleate 2 MG / chlophedianol hydrochloride 12.5 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution	SY	7ba8db45-f5b6-5d32-e053-2991aa0a77b7	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58407-252-04	58407025204	118 mL in 1 BOTTLE (58407-252-04)	118 ml	2018-11-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATUSS DA	Magna Pharmceuticals, Inc. \| Woodfield Pharmaceutical, LLC	2021-11-02	HUMAN OTC DRUG LABEL	4