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 firm2026-10-27

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 157 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEAmerican Health Packaging4cd8aee3-5522-434b-a1b1-9591bed3e9a62024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging8632a655-7f5b-450f-95fa-62478a174e9c2024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging990906b3-c566-4f35-923c-060202ba48e02024-08-04WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropsHONEY LEMON FLAVOR MENTHOLWHOLE FOODS MARKET, INC.1eb7abdc-061f-0e18-e063-6294a90a3a652024-08-02WarningsExact identifier
application number: M012
Herbal Flavor Menthol Cough DropsHERBAL FLAVOR MENTHOL COUGH DROPSWHOLE FOODS MARKET, INC.1eb848b6-3dec-5b5f-e063-6394a90aea142024-08-02WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOL COUGH DROPSWHOLE FOODS MARKET, INC.1eb8927b-22c5-2ca3-e063-6294a90aa5632024-08-02WarningsExact identifier
application number: M012
No Drip Severe Anefrin Nasal0.05% OXYMETAZOLINE HCLWalgreens Companyc126e969-56f3-47b4-a011-02ff150eccb82024-08-02WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation90e0426b-654f-4bcd-8b1d-cf56d1fc0c682024-07-27WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HCLA-S Medication Solutions0e81a937-59e5-4869-8ffb-c758fb37230d2024-07-23WarningsExact identifier
application number: M012
WesTussin DMDEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWestminster Pharmaceuticals, LLC68a0cd44-3fdd-430e-af1a-498d4415ab782024-07-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGLil' Drug Store Products, Inc.edc244d6-eb0b-d3c9-e053-2a95a90a26222024-07-22WarningsExact identifier
application number: M012
Night Time Sleep AidDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)1f3eeb6c-4c44-4e2a-ad72-12c95e6589c92024-07-22WarningsExact identifier
application number: M012
CareOne Childrens Allergy ReliefDIPHENHYDRAMINE HCLAmerican Sales Companybb78ef2c-4f42-4e8f-b38d-f9b2965a384b2024-07-19WarningsExact identifier
application number: M012
dg health allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp, LLC71445443-34bd-4d8c-b9c8-e7c3b8d4c8322024-07-19WarningsExact identifier
application number: M012
basic care childrens allergy reliefDIPHENHYDRAMINE HCLAmazon.com Services LLC75b9ee90-ad26-433e-8b90-97441b8d1e152024-07-19WarningsExact identifier
application number: M012
Cold and Flu Severe Day and NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC9b74dd00-8f84-4fce-b5ea-df886b5953262024-07-18WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.4872dfdd-0df6-47ae-87f2-8049191cd4822024-07-18WarningsExact identifier
application number: M012
equate allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Incb05acd16-21cb-4ee0-afa0-8f7d591664352024-07-18WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLPublix Super Markets Inccc6e4e26-84f5-4003-b1eb-f0e06d3e294e2024-07-18WarningsExact identifier
application number: M012
childrens allergyDIPHENHYDRAMINE HYDROCHLORIDEKroger Company10ebc7f8-dc8a-4640-8f87-d0d073998fd52024-07-18WarningsExact 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