FDA.reportPublic FDA data

Primatene

Product NDC
80070-600
11-digit product format
800700600
Labeler code
80070
Product ID
80070-600_2657d074-46cb-bc95-e063-6294a90aeec8
Type
HUMAN OTC DRUG
Nonproprietary name
EPHEDRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Foundation Consumer Brands
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-22
Substance
EPHEDRINE HYDROCHLORIDE
Active strength
12.5 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
2026-12-31
Current FDA listing
Yes

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
Primatene
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPHEDRINE HYDROCHLORIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NLJ6390P1ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2534871Internal RxNorm lookup
2591390Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2170f081-c03f-47e8-bc63-4052c5e653faAvailable on FDA.report

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
80070-600-24Primatene2 in 1 CARTONTABLET22
80070-600-24Primatene12 in 1 BLISTER PACKTABLET122
80070-600-60Primatene12 in 1 BLISTER PACKTABLET122
80070-600-60Primatene5 in 1 CARTONTABLET52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80070-600PRIMATENE (EPHEDRINE HYDROCHLORIDE) TABLET [FOUNDATION CONSUMER BRANDS]2Current NDC, Legacy NDC, 4 package rows20241109_2170f081-c03f-47e8-bc63-4052c5e653fa.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 112 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c55543-e05e-2f7c-e063-6394a90a45342025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.38049d29-f47e-9478-e063-6294a90aa2a42025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Menthol Sugar FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3804a271-9a11-848d-e063-6394a90af87d2025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Menthol Sugar FreeMENTHOLArmy & Air Force Exchange Service3805ef07-247d-0df7-e063-6394a90ac45b2025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drop Black Cherry Sugar FreeMENTHOLArmy & Air Force Exchange Service3805f8f5-562f-0ba8-e063-6394a90ac9d92025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-FreeMENTHOLArmy & Air Force Exchange Service3805f90e-bd89-128d-e063-6394a90afa012025-06-20WarningsExact identifier
application number: M012
TARGET Multi Symptom Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTARGET CORPORATIONaebe3c15-53ef-46ea-af39-8c9b8114595f2025-06-20WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTCbe95332d-a2e0-42e8-bfb3-8850d74990ff2025-06-19WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTC37e939c6-064b-3548-e063-6294a90a337d2025-06-19WarningsExact identifier
application number: M012
Capron DMDEXTROMETHORPHAN HBR AND PYRILAMINE MALEATECapital Pharmaceutical, LLCcf778c5f-475e-4a86-a87c-2be1e665f5a52025-06-18WarningsExact identifier
application number: M012
Cough OutGUAIFENESINEfficient Laboratories Inc.fe4c3921-8d30-4cd6-ba90-9211b362a38a2025-06-18WarningsExact identifier
application number: M012
Guaifenesin STRAWBERRY-BANANA FLAVORGUAIFENESINInnovida Pharmaeutique Corporation1006906e-d6d7-4f49-92bf-3cb2d2cdbb162025-06-18WarningsExact identifier
application number: M012
Mucinex Sinus Max Clear and CoolACETAMINOPHEN AND GUAIFENESINRB Health (US) LLC37de813a-54b7-672a-e063-6294a90a374e2025-06-18WarningsExact identifier
application number: M012
childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a1aeb41-a8fa-4116-8068-e11acd608e582025-06-18WarningsExact identifier
application number: M012
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIXACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c768f5-dabd-22d0-e063-6394a90af9e52025-06-17WarningsExact identifier
application number: M012
DISCOUNT DRUG MART Childrens Allergy ChewableDIPHENHYDRAMINE HCLDISCOUNT DRUG MART51de95da-e8e8-48f0-9fa4-6191aa4a247b2025-06-16WarningsExact identifier
application number: M012
Halls CherryMENTHOLMondelez Global LLC5f4af8e8-8550-45c7-a199-694efac9e7be2025-06-16WarningsExact identifier
application number: M012
Halls Honey LemonMENTHOLMondelez Global LLC25eaae85-d516-40da-a472-70736ea2b75d2025-06-16WarningsExact identifier
application number: M012
Halls CherryMENTHOLMondelez Global LLCbad89968-22a7-4287-a57c-9e6206e574fe2025-06-16WarningsExact identifier
application number: M012
Herbal Throat DropsLEMON MINT HERBALMeijer, Inc.37dd58ad-95d1-568c-e063-6394a90a94332025-06-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2534871ePHEDrine HCl 12.5 MG Oral TabletPSN2170f081-c03f-47e8-bc63-4052c5e653fa2
2591390Primatene with ePHEDrine 12.5 MG Oral TabletPSN2170f081-c03f-47e8-bc63-4052c5e653fa2
2591390ephedrine hydrochloride 12.5 MG Oral Tablet [Primatene with ephedrine]SBD2170f081-c03f-47e8-bc63-4052c5e653fa2
2534871ephedrine hydrochloride 12.5 MG Oral TabletSCD2170f081-c03f-47e8-bc63-4052c5e653fa2
2534871ephedrine HCl 12.5 MG Oral TabletSY2170f081-c03f-47e8-bc63-4052c5e653fa2
2591390Primatene with ephedrine 12.5 MG Oral TabletSY2170f081-c03f-47e8-bc63-4052c5e653fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80070-600-24800700600242 BLISTER PACK in 1 CARTON (80070-600-24) / 12 TABLET in 1 BLISTER PACK2 blister pack2021-01-220000-00-00NoNoCurrent
80070-600-60800700600605 BLISTER PACK in 1 CARTON (80070-600-60) / 12 TABLET in 1 BLISTER PACK5 blister pack2021-01-220000-00-00NoNoCurrent