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 2 of 354 · 7,063 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
unii: 04JA59TNSJ
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
unii: TC2D6JAD40
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
unii: 362O9ITL9D
Pain and Fever ChildrensACETAMINOPHENDOLGENCORP, LLCc637b39c-a049-43af-a582-fc242e940d852026-09-08WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: 04JA59TNSJ
unii: TC2D6JAD40
unii: 362O9ITL9D
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyf7667529-09c0-4603-8080-f236144fac362026-09-08WarningsExact identifier
unii: 362O9ITL9D
UP AND UP CHILDRENS ACETAMINOPHENACETAMINOPHENTarget Corporatione2989ead-7fdc-4295-bf94-4231957756702026-09-08WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENRite Aid Corporationd846065a-5c39-4f4b-894c-4280acaaf4fa2026-09-08WarningsExact identifier
unii: 362O9ITL9D
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association, Inc.2a7afe03-3c34-4e30-827e-b3bb2568cb972026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
unii: TC2D6JAD40
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsExact identifier
unii: 362O9ITL9D
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsExact identifier
unii: 362O9ITL9D
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
unii: 362O9ITL9D
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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