Quality Choice Nighttime Severe Cold and Cough

Product NDC
63868-764
11-digit product format
638680764
Labeler code
63868
Product ID
63868-764_28c1544e-adc6-55b7-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-12-02
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-764-062020-01-31C16284748780-19d75b9d0-8062-f424-e053-dadaa90a57ceQuality Choice Nighttime Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea Flavors

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-764-06Quality Choice Nighttime Severe Cold and CoughHoney Lemon infused with Chamomile and White Tea Flavors6 in 1 BOXGRANULE, FOR SOLUTION62

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DQUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40QUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJQUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
AcetaminophenACTIVE MOIETY362O9ITL9DQUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MQUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
PhenylephrineACTIVE MOIETY1WS297W6MVQUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
AcesulfameINACTIVE INGREDIENTMA3UYZ6K1HQUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
AspartameINACTIVE INGREDIENTZ0H242BBR1QUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
Citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPQUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DQUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRQUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
SucroseINACTIVE INGREDIENTC151H8M554QUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-764QUALITY CHOICE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]2Legacy NDC, 1 package rows20160107_c1d648ff-1b19-403e-a945-ee6a8c5fc2ac.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 SolutionPSNc1d648ff-1b19-403e-a945-ee6a8c5fc2ac2
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDc1d648ff-1b19-403e-a945-ee6a8c5fc2ac2
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYc1d648ff-1b19-403e-a945-ee6a8c5fc2ac2
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYc1d648ff-1b19-403e-a945-ee6a8c5fc2ac2
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYc1d648ff-1b19-403e-a945-ee6a8c5fc2ac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-764-06638680764066 in 1 BOXHistorical