Rite Aid Nighttime Severe Cold and Cough Relief

Product NDC
11822-2113
11-digit product format
118222113
Labeler code
11822
Product ID
11822-2113_9139f9de-61d0-44fa-9324-2e466ec8e1a7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Rite Aid Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-28
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

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 productproduct11822-2113IInactivated by FDA2026-10-12
excluded packagepackage11822-211311822-2113-7IInactivated by FDA2026-10-12

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 packagepackage11822-2113-7d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11822-2113-7f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11822-2113-72ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11822-2113-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11822-2113-7cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11822-2113-7cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11822-2113-7302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11822-2113-7ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11822-2113-70efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11822-2113-7ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11822-2113-7367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11822-2113-7557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11822-2113-78af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11822-2113-7834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11822-2113-71332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11822-2113-7fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11822-2113-786f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11822-2113-7bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage11822-2113-78dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11822-2113-7e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11822-2113-79bebd1f3094a…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
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
11822-2113-72020-01-31C16284748780-19d75b9d0-c919-f424-e053-dadaa90a57ceRite Aid ® Nighttime Severe Cold & Cough Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-2113-7Rite Aid Nighttime Severe Cold and Cough Relief6 in 1 CARTONPOWDER, FOR SOLUTION62

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DRITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
Diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40RITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
Phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJRITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
AcetaminophenACTIVE MOIETY362O9ITL9DRITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
DiphenhydramineACTIVE MOIETY8GTS82S83MRITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
PhenylephrineACTIVE MOIETY1WS297W6MVRITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9RITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLRITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
anhydrous trisodium citrateINACTIVE INGREDIENTRS7A450LGARITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
aspartameINACTIVE INGREDIENTZ0H242BBR1RITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GRITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDRITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOARITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DRITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
sucroseINACTIVE INGREDIENTC151H8M554RITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-2113RITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2Legacy NDC, 1 package rows20150424_63ff5e77-324c-469a-aed3-8d444c7ea704.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 SolutionPSN63ff5e77-324c-469a-aed3-8d444c7ea7042
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD63ff5e77-324c-469a-aed3-8d444c7ea7042
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY63ff5e77-324c-469a-aed3-8d444c7ea7042
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY63ff5e77-324c-469a-aed3-8d444c7ea7042
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY63ff5e77-324c-469a-aed3-8d444c7ea7042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11822-2113-7118222113076 in 1 CARTONHistorical