Head Congestion Cold Relief

Product NDC
59779-470
11-digit product format
597790470
Labeler code
59779
Product ID
59779-470_bddddfc8-2fdf-7e68-7422-1c1656705a87
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2006-06-11
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-470-012020-01-31C16284748780-19d75b9d0-af66-f424-e053-dadaa90a57ceebe9d74d-d382-1cdc-a5ea-94070cb5e6ac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-470-01Head Congestion Cold Relief1 in 1 CARTONTABLET, FILM COATED11
59779-470-01Head Congestion Cold Relief12 in 1 BLISTER PACKTABLET, FILM COATED121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
AcetaminophenACTIVE MOIETY362O9ITL9DHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
DextromethorphanACTIVE MOIETY7355X3ROTSHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
PhenylephrineACTIVE MOIETY1WS297W6MVHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48HEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30HEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
Polyethylene GlycolINACTIVE INGREDIENT3WJQ0SDW1AHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
Polyvinyl AlcoholINACTIVE INGREDIENT532B59J990HEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
PovidoneINACTIVE INGREDIENTFZ989GH94EHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4HEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4HEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
TalcINACTIVE INGREDIENT7SEV7J4R1UHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPHEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-470HEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1Legacy NDC, 2 package rows20100914_ebe9d74d-d382-1cdc-a5ea-94070cb5e6ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094538acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSNebe9d74d-d382-1cdc-a5ea-94070cb5e6ac1
1094538acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDebe9d74d-d382-1cdc-a5ea-94070cb5e6ac1
1094538APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSYebe9d74d-d382-1cdc-a5ea-94070cb5e6ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
59779-470-01597790470011 in 1 CARTONHistorical