Chloraseptic Nighttime Sore Throat Hot Relief

Product NDC
67172-150
11-digit product format
671720150
Labeler code
67172
Product ID
67172-150_726cdf80-c05c-4a6a-8d3e-a80f12f1acab
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen and diphenhydramine hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Prestige Brands Holdings, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-20
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
650; 25 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Chloraseptic Nighttime Sore Throat Hot Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2670677Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c13c052-a5d1-43d2-8d29-4ea011a971acAvailable on FDA.report

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 148 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe3dd12f1-dd63-27ae-e053-2995a90aaaeb2024-10-17WarningsExact identifier
application number: M012
COLD and FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe44ac549-3e9b-4271-a2b2-ecb124f798322024-10-17WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTf171a389-8b22-429c-86bc-272156fdc1b72024-10-17WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART6c5b5427-e47a-4eff-928a-c891452facf92024-10-17WarningsExact identifier
application number: M012
COLD AND FLU SEVEREACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTddeb8978-84b6-4a19-b25e-99d1c29e58d92024-10-17WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20baef9-6e68-6679-e053-2a95a90a2b632024-10-17WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20b71fb-8787-c871-e053-2a95a90a8eb42024-10-17WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20bc492-fed3-bf05-e053-2a95a90ad3932024-10-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIa4d6ecb9-ea67-41ed-917b-9bb4d1e505512024-10-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI08fda81a-bedd-4ff3-9c32-2066d2cea3f92024-10-17WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINAmerican Health Packaging2fd702ea-3069-472c-b99e-c527f13757052024-10-17WarningsExact identifier
application number: M012
Mucus Relief XpectGUAIFENSIN, DEXTROMETHORPHANSelder, S.A. de C.V.c2b49d10-b60f-3072-e053-2a95a90af0042024-10-17WarningsExact identifier
application number: M012
Head Congestion plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI1db914d3-8bba-405e-9bf9-9b1a5806284c2024-10-17WarningsExact identifier
application number: M012
Cold Medicine XL3ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.e2c35fae-9dd6-51f2-e053-2995a90a1e9e2024-10-17WarningsExact identifier
application number: M012
Cough and Cold XL3 XtraACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.da5b31dd-becd-471a-9392-d0ee4b8f95392024-10-17WarningsExact identifier
application number: M012
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMIDWAY IMPORTING INC.58252f15-485c-3061-e053-2a91aa0a23202024-10-17WarningsExact identifier
application number: M012
Cold Medicine XL3ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMidway Importing, Inc.e41b9beb-e274-5c02-e053-2995a90ad0f82024-10-17WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC38e70a28-eff2-4a48-b829-8cd68e80beef2024-10-17WarningsExact identifier
application number: M012
Mucus Relief XpectGUAIFENSIN, DEXTROMETHORPHANMidway Importing Inc.c2c8bd26-bbf1-c2e6-e053-2995a90a86a72024-10-17WarningsExact identifier
application number: M012
Antiflu Des Cough and FluACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATEProductos Farmaceuticos, S.A. de C.V.dcf3897a-a793-6df7-e053-2995a90a25f82024-10-17WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67172-150-06671720150066 POWDER, FOR SOLUTION in 1 CARTON (67172-150-06) 2026-06-20NoNoCurrent