FDA.reportPublic FDA data

Ephedrine Sulfate

Product NDC
69842-922
11-digit product format
698420922
Labeler code
69842
Product ID
69842-922_5c2ce363-376f-6476-e063-6394a90aa07a
Type
HUMAN OTC DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-28
Substance
EPHEDRINE SULFATE
Active strength
25 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69842-92269842-922-07DDiscontinued by firm2026-10-23

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Ephedrine Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPHEDRINE SULFATE25 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1bd959e-e326-44fb-b8ca-8c56a84a2a3dProduct name220251211
f1d178e1-1663-4c63-ae37-62a1b322fba4Product name220251106
f606d3ac-dd63-4b29-bea0-db23753b8ddcProduct name120220118
30254138-2d98-4aa2-8e07-ae82e8b0a389Product name320171103
fee762de-ffd9-404d-8bc6-8c0c208e758dProduct name120170426

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-922-07Ephedrine Sulfate5 in 1 CARTONTABLET, FILM COATED53
69842-922-07Ephedrine Sulfate12 in 1 BLISTER PACKTABLET, FILM COATED123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-922EPHEDRINE SULFATE TABLET, FILM COATED [CVS PHARMACY, INC]3Current NDC, 2 package rows20241208_e338deef-efad-1d82-e053-2995a90a1bf9.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 127 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Afrin OriginalOXYMETAZOLINE HYDROCHLORIDELil' Drug Store Products, Inc.8a97c012-6a47-4607-9389-58a4eed17b082024-12-18WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILOrazen Incecddaa3b-e18f-1c74-e053-2995a90ad86a2024-12-18WarningsExact identifier
application number: M012
Rite Aid Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLRite Aiddfedbef1-8062-432d-e053-2a95a90a09e92024-12-18WarningsExact identifier
application number: M012
TheraCare Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILVeridian Healthcaref7801843-f96c-710e-e053-6294a90a50862024-12-18WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief G450GUAIFENESINRugby Laboratoriesa6aa8cbd-21ff-4f84-b338-c05c2d46e6df2024-12-18WarningsExact identifier
application number: M012
Refenesen Mucus ReliefGUAIFENESINReese Pharmaceutical Co861dffb7-8bf4-4f03-bcc2-ed8a35bc341d2024-12-18WarningsExact identifier
application number: M012
Marcs Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINMarc Glassman Incbe3ad54f-522c-440d-b8c7-9664f60155662024-12-18WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINStrategic Sourcing Services LLCda6bd9df-aebe-4fe5-b20b-01bda3b9e7ee2024-12-18WarningsExact identifier
application number: M012
Family Wellness Chest Congestion ReliefGUAIFENESINFamily Dollar Services Inc412f3459-4c22-4822-86bd-011fc3e91ca62024-12-18WarningsExact identifier
application number: M012
Marcs Mucus ReliefGUAIFENESINMarc Glassman Inc455b9f01-206c-4534-a006-292d2bd48f472024-12-18WarningsExact identifier
application number: M012
Leader Chest Congestion Relief G450GUAIFENESINCardinal Health4586a83f-077c-4fb3-adfe-7a9497a78d972024-12-18WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINStrategic Sourcing Services LLC5372f764-985e-4a42-bc97-cb0dc90fcd9c2024-12-18WarningsExact identifier
application number: M012
TopCare Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINTOPCO ASSOCIATES LLC5a2d0464-038d-4c3f-b39e-ee9984fb383e2024-12-18WarningsExact identifier
application number: M012
Always Save Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINValu Mercha72b6a97-f97f-44bb-8d55-ac48b8ba45c52024-12-18WarningsExact identifier
application number: M012
Harris Teeter Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter4ebe1d94-bb15-4250-a4c2-8cd45743c7dd2024-12-18WarningsExact identifier
application number: M012
Care One Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINRETAIL BUSINESS SERVICES , LLCf6657dee-9f32-45b1-8e44-1ad67a4a68bd2024-12-18WarningsExact identifier
application number: M012
Childrens Metapp DaytimeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLGuardian Drug Company40565500-944b-47f2-8563-5df05469e4182024-12-18WarningsExact identifier
application number: M012
CVS Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINCVS Pharmacy, Inc.884abed2-e355-4134-92f1-591f3a18f71d2024-12-18WarningsExact identifier
application number: M012
CVS Health Chest Congestion Relief PEGUAIFENESIN/PHENYLEPHRINECVS Pharmacy, Inc.a49020e8-739e-47ec-8141-e866479a3ab32024-12-18WarningsExact identifier
application number: M012
Family Wellness Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINFamily Dollar Services Inc8aee8108-a4e0-4956-8e37-6b3b1c5dc6832024-12-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116194ePHEDrine sulfate 25 MG Oral TabletPSNe338deef-efad-1d82-e053-2995a90a1bf93
1116194ephedrine sulfate 25 MG Oral TabletSCDe338deef-efad-1d82-e053-2995a90a1bf93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69842-922-07698420922075 in 1 CARTONHistorical