Pain Reliever Fever Reducer

Product NDC
76168-021
11-digit product format
761680021
Labeler code
76168
Product ID
76168-021_240453b0-189a-401e-9f2e-2bf977f7aaa6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen,Dextromethorphan hydrobromide,Phenylephrine Hydrochloride,Chlorpheniramine Maleate
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Velocity Pharma
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-08-15
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength
250 mg/1; mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76168-021-132020-01-31C16284748780-19d75b9d1-235e-f424-e053-dadaa90a57ceAcetaminophen, Chlorpheniramine maleate, Dextromethorphan HBrand Phenylephrine HCl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-021-13Pain Reliever Fever Reducer6 in 1 BLISTER PACKTABLET, EFFERVESCENT61
76168-021-13Pain Reliever Fever Reducer1 in 1 CARTONTABLET, EFFERVESCENT11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
PONCEAU 4RINACTIVE INGREDIENTZ525CBK9PGPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOPAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-021PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]1Legacy NDC, 2 package rows20140825_8600db56-a877-4557-ab71-d46b72d642c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Effervescent Oral TabletPSN8600db56-a877-4557-ab71-d46b72d642c91
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral TabletSCD8600db56-a877-4557-ab71-d46b72d642c91
1536477APAP 250 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Effervescent Oral TabletSY8600db56-a877-4557-ab71-d46b72d642c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76168-021-13761680021136 in 1 BLISTER PACKHistorical