FDA.reportPublic FDA data

NDC 54473-184-01 - CounterAct Night

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
54473-184
Requested NDC
54473-184-01
Package NDCs from labels
54473-184-01, 54473-184-36
Manufacturer
Melaleuca, Inc.
Effective date
2019-12-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CounterAct Night Content of LabelMelaleuca, Inc.2019-12-09HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40COUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48COUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOUNTERACT NIGHT (ACETAMINOPHEN, DIPHENYDRAMINE HCI, PHENYLEPHRINE HCI) TABLET, COATED [MELALEUCA, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 354 · 7,063 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company1022767d-a456-4fbc-95cf-91337c74c3302026-10-01WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
unii: 362O9ITL9D
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
unii: TC2D6JAD40
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporation7f445de3-30cf-4bd8-892d-05979cd399e72026-09-09WarningsExact identifier
unii: 362O9ITL9D
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsExact identifier
unii: 362O9ITL9D
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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