flu and severe cold and cough

Product NDC
56062-964
11-digit product format
560620964
Labeler code
56062
Product ID
56062-964_4c6f1707-e991-4c24-82a2-6b5c74eea35c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Publix Super Markets Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-09-29
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 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
2023-12-31
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 productproduct56062-964DDiscontinued by firm2026-10-15
excluded packagepackage56062-96456062-964-91DDiscontinued by firm2026-10-15

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 · 22 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 packagepackage56062-964-91d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage56062-964-91f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage56062-964-912ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage56062-964-91a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage56062-964-91cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage56062-964-91cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage56062-964-91302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage56062-964-91ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage56062-964-910efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage56062-964-91ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage56062-964-91367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
56062-964-912024-01-30C16284748780-11030e365-4209-111a-e063-dadaa90a10e2Publix Super Markets, Inc. Flu & Severe Cold & Cough Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DFLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJFLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DFLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MFLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVFLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DFLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRFLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
SUCROSEINACTIVE INGREDIENTC151H8M554FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [PUBLIX SUPER MARKETS INC]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
56062-964-91560620964916 POWDER, FOR SOLUTION in 1 CARTON (56062-964-91) 2011-09-290000-00-00NoNoCurrent