Nighttime Severe Cold and Cough

Product NDC
41226-541
11-digit product format
412260541
Labeler code
41226
Product ID
41226-541_3b87f717-d2f5-f93a-e063-6394a90a3447
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
KROGER COMPANY
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-15
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 25; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 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
Nighttime Severe Cold and Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40, 04JA59TNSJ
Rxcui1659960

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-541-06Nighttime Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-541NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE) POWDER, FOR SOLUTION [KROGER COMPANY]2Current NDC, 1 package rows20240326_7def6781-0881-46bf-ad7a-7a3f23a8d9f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN7def6781-0881-46bf-ad7a-7a3f23a8d9f73
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD7def6781-0881-46bf-ad7a-7a3f23a8d9f73
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY7def6781-0881-46bf-ad7a-7a3f23a8d9f73
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY7def6781-0881-46bf-ad7a-7a3f23a8d9f73
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY7def6781-0881-46bf-ad7a-7a3f23a8d9f73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
41226-541-06412260541066 POWDER, FOR SOLUTION in 1 CARTON (41226-541-06) 2024-01-15NoNoCurrent