Quality Choice Daytime Severe Cold and Cough

Product NDC
63868-763
11-digit product format
638680763
Labeler code
63868
Product ID
63868-763_28b21bb0-32b1-0954-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-11-18
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-763IInactivated by FDA2026-10-16
excluded packagepackage63868-76363868-763-06IInactivated by FDA2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63868-763-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63868-763-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63868-763-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63868-763-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63868-763-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63868-763-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63868-763-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63868-763-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63868-763-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63868-763-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63868-763-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63868-763-06557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63868-763-068af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63868-763-06834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63868-763-061332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63868-763-06fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63868-763-0686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63868-763-06bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63868-763-068dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63868-763-06e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63868-763-069bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-763-062020-01-31C16284748780-19d75b9d1-0480-f424-e053-dadaa90a57ceQuality Choice Daytime Severe Cold and Cough Berry Infused with Menthol and Green Tea Flavors

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-763-06Quality Choice Daytime Severe Cold and CoughBerry infused with Menthol and Green Tea flavors6 in 1 BOXGRANULE, FOR SOLUTION62

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DQUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHQUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJQUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
AcetaminophenACTIVE MOIETY362O9ITL9DQUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSQUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
PhenylephrineACTIVE MOIETY1WS297W6MVQUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
AcesulfameINACTIVE INGREDIENTMA3UYZ6K1HQUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
AspartameINACTIVE INGREDIENTZ0H242BBR1QUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
Citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPQUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DQUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRQUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
SucroseINACTIVE INGREDIENTC151H8M554QUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR 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
63868-763QUALITY CHOICE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]2Legacy NDC, 1 package rows20160107_780a7447-63f9-4126-985e-5afa0a942cc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN780a7447-63f9-4126-985e-5afa0a942cc52
1659967acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD780a7447-63f9-4126-985e-5afa0a942cc52
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionSY780a7447-63f9-4126-985e-5afa0a942cc52
1659967APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY780a7447-63f9-4126-985e-5afa0a942cc52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-763-06638680763066 in 1 BOXHistorical