Rite Aid day time severe cold and cough

Product NDC
64525-0551
11-digit product format
645250551
Labeler code
64525
Product ID
64525-0551_e6568ab9-b334-490f-b01d-64547dbae26f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL.
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Quality Home Products
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-10-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/1; mg/1; mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct64525-0551IInactivated by FDA2026-10-16
excluded packagepackage64525-055164525-0551-6IInactivated 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64525-0551-6IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64525-0551-6IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64525-0551-6IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64525-0551-6IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64525-0551-6IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64525-0551-6IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64525-0551-6IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64525-0551-6IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64525-0551-6IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64525-0551-6IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64525-0551-6IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64525-0551-6IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64525-0551-6IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64525-0551-6IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64525-0551-6IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64525-0551-6IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64525-0551-6IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64525-0551-6IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64525-0551-6IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64525-0551-6IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64525-0551-6IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage64525-0551-6EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64525-0551-62020-01-31C16284748780-19d75b9d0-5d3d-f424-e053-dadaa90a57ceDay time Severe Cold and cough berry infused with menthol and green tea flavors

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64525-0551-6Rite Aid day time severe cold and cough berry infused with menthol and green tea flavors6 in 1 BOXGRANULE, FOR SOLUTION62

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DRITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHRITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJRITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2
AcetaminophenACTIVE MOIETY362O9ITL9DRITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2
DextroseACTIVE MOIETYIY9XDZ35W2RITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2
PhenylephrineACTIVE MOIETY1WS297W6MVRITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2
AcesulfameINACTIVE INGREDIENTMA3UYZ6K1HRITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2
AspartameINACTIVE INGREDIENTZ0H242BBR1RITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPRITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DRITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRRITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2
SucroseINACTIVE INGREDIENTC151H8M554RITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64525-0551RITE AID DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [QUALITY HOME PRODUCTS]2Legacy NDC, 1 package rows20091031_8b0df600-2d16-4815-a786-794be34f6c95.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 SolutionPSN8b0df600-2d16-4815-a786-794be34f6c952
1659967acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD8b0df600-2d16-4815-a786-794be34f6c952
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionSY8b0df600-2d16-4815-a786-794be34f6c952
1659967APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY8b0df600-2d16-4815-a786-794be34f6c952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64525-0551-6645250551066 in 1 BOXHistorical