Red Label Ephedrine Plus

Product NDC: 65193-125
Requested package NDC: 65193-125-48
11-digit product format: 651930125
Labeler code: 65193
Product ID: 65193-125_d63abbf4-7716-4a78-86d3-d9539aa7a4d9
Type: HUMAN OTC DRUG
Nonproprietary name: ephedrine hydrochloride, guaifenesin
Dosage form: TABLET
Route: ORAL
Labeler: Dickey Consumer Products DBA DMD
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-04-02
Marketing end: 0000-00-00
Substance: EPHEDRINE HYDROCHLORIDE; GUAIFENESIN
Active strength: 13 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	65193-125	65193-125-48	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
d1bd959e-e326-44fb-b8ca-8c56a84a2a3d	Product name	2	20251211
f1d178e1-1663-4c63-ae37-62a1b322fba4	Product name	2	20251106
f606d3ac-dd63-4b29-bea0-db23753b8ddc	Product name	1	20220118
30254138-2d98-4aa2-8e07-ae82e8b0a389	Product name	3	20171103
fee762de-ffd9-404d-8bc6-8c0c208e758d	Product name	1	20170426
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65193-125-48	2023-01-30	C162847	48780-1	f386c64a-219b-0266-e053-dadaa90a7c1a	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65193-125-48	Red Label Ephedrine Plus	48 in 1 BLISTER PACK	TABLET	48		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65193-125	RED LABEL EPHEDRINE PLUS (EPHEDRINE HYDROCHLORIDE, GUAIFENESIN) TABLET [DICKEY CONSUMER PRODUCTS DBA DMD]	1	Legacy NDC, 1 package rows	20190403_bc11389f-c988-4f67-a56e-6eaad5cb1883.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NLJ6390P1Z	EPHEDRINE HYDROCHLORIDE	50-98-6	EPHEDRINE HYDROCHLORIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1115991	ePHEDrine HCl 12.5 MG / guaiFENesin 200 MG Oral Tablet	PSN	bc11389f-c988-4f67-a56e-6eaad5cb1883	1
1115991	ephedrine hydrochloride 12.5 MG / guaifenesin 200 MG Oral Tablet	SCD	bc11389f-c988-4f67-a56e-6eaad5cb1883	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65193-125-48	65193012548	48 TABLET in 1 BLISTER PACK (65193-125-48)	48 tablet	2019-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Dickey Consumer Products DBA DMD \| Ultratab Laboratories, Inc. \| Ultra Seal Corp.	2019-04-02	HUMAN OTC DRUG LABEL	1