FDA.reportPublic FDA data

Bronkaid

Product NDC
69536-250
11-digit product format
695360250
Labeler code
69536
Product ID
69536-250_e406ff56-f8d4-49e8-b5ba-8c94bcf8052f
Type
HUMAN OTC DRUG
Nonproprietary name
EPHEDRINE SULFATE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Foundation Consumer Healthcare LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bronkaid
Brand name suffix
Max
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPHEDRINE SULFATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6X61U5ZEG
Rxcui1116194, 2396449

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69536-250-242024-03-14C16284748780-11030e365-4b5b-111a-e063-dadaa90a10e2Bronkaid ® Max
69536-250-602024-03-14C16284748780-11030e365-4b5b-111a-e063-dadaa90a10e2Bronkaid ® Max
69536-250-242024-01-30C16284748780-11030e365-4b5b-111a-e063-dadaa90a10e2Bronkaid ® Max
69536-250-602024-01-30C16284748780-11030e365-4b5b-111a-e063-dadaa90a10e2Bronkaid ® Max

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-250-24Bronkaid Max6 in 1 BLISTER PACKTABLET, COATED62
69536-250-24Bronkaid Max4 in 1 CARTONTABLET, COATED42
69536-250-60Bronkaid Max12 in 1 BLISTER PACKTABLET, COATED122
69536-250-60Bronkaid Max5 in 1 CARTONTABLET, COATED52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-250BRONKAID MAX (EPHEDRINE SULFATE) TABLET, COATED [FOUNDATION CONSUMER HEALTHCARE LLC]2Current NDC, Legacy NDC, 4 package rows20240316_9a0b792a-caee-41f6-9400-922a5ebd592f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2396449Bronkaid Max 25 MG Oral TabletPSN9a0b792a-caee-41f6-9400-922a5ebd592f2
1116194ePHEDrine sulfate 25 MG Oral TabletPSN9a0b792a-caee-41f6-9400-922a5ebd592f2
2396449ephedrine sulfate 25 MG Oral Tablet [Bronkaid Max]SBD9a0b792a-caee-41f6-9400-922a5ebd592f2
1116194ephedrine sulfate 25 MG Oral TabletSCD9a0b792a-caee-41f6-9400-922a5ebd592f2
2396449Bronkaid Max 25 MG Oral TabletSY9a0b792a-caee-41f6-9400-922a5ebd592f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69536-250-24695360250244 BLISTER PACK in 1 CARTON (69536-250-24) / 6 TABLET, COATED in 1 BLISTER PACK4 blister pack2020-09-010000-00-00NoNoCurrent
69536-250-60695360250605 BLISTER PACK in 1 CARTON (69536-250-60) / 12 TABLET, COATED in 1 BLISTER PACK5 blister pack2020-09-010000-00-00NoNoCurrent