Cold Head Congestion

Product NDC
37205-756
Requested package NDC
37205-756-62
11-digit product format
372050756
Labeler code
37205
Product ID
37205-756_15d48c48-2d17-4b76-a456-b3ff577a0281
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CARDINAL HEALTH
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-07-15
Marketing end
2022-03-20
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37205-75637205-756-62DDiscontinued by firm2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-756-62EA - Each37205-75644551ccb-98e5-41be-b76a-6be0fb58047812014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCOLD HEAD CONGESTION DAYTIME NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [CARDINAL HEALTH]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOLD HEAD CONGESTION DAYTIME NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [CARDINAL HEALTH]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD HEAD CONGESTION DAYTIME NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [CARDINAL HEALTH]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD HEAD CONGESTION DAYTIME NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [CARDINAL HEALTH]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOLD HEAD CONGESTION DAYTIME NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [CARDINAL HEALTH]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD HEAD CONGESTION DAYTIME NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [CARDINAL HEALTH]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOLD HEAD CONGESTION DAYTIME NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [CARDINAL HEALTH]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOLD HEAD CONGESTION DAYTIME NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [CARDINAL HEALTH]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCOLD HEAD CONGESTION DAYTIME NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [CARDINAL HEALTH]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLD HEAD CONGESTION DAYTIME NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [CARDINAL HEALTH]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37205-756-62372050756621 BLISTER PACK in 1 BOX (37205-756-62) > 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2005-07-152022-03-20NoNoCurrent