FDA.reportPublic FDA data

Theraflu Flu Relief Max Strength

Product NDC
0067-8205
11-digit product format
000678205
Labeler code
0067
Product ID
0067-8205_446e5d67-95c9-e039-e063-6294a90a6cfa
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
SYRUP
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-27
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
1000; 4; 30 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Theraflu Flu Relief Max Strength
Brand name suffix
Nighttime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN1000 mg/30mL
CHLORPHENIRAMINE MALEATE4 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
V1Q0O9OJ9ZInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2604562Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
780907b8-34ba-4ec8-bcdf-b2a31bd111dfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
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79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
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c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8205-01Theraflu Flu Relief Max StrengthNighttime245.5 mL in 1 BOTTLESYRUP245.55
0067-8205-01Theraflu Flu Relief Max StrengthDaytime Nighttime Value Pack245.5 mL in 1 BOTTLESYRUP245.5 mL30 mg in 30mL4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-8205-01ML - Milliliter0067-82054caa04a4-1310-43be-828c-7d6dca78e82a12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8205THERAFLU FLU RELIEF MAX STRENGTH NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) SYRUP [HALEON US HOLDINGS LLC]4Current NDC, 1 package rows20250115_780907b8-34ba-4ec8-bcdf-b2a31bd111df.zip
0067-8205THERAFLU FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC]3Current NDC20240310_3618ccf0-1f30-42e0-bb50-bfa45cf2b583.zip

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 170 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RESFRIOL DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLC0e9c96b9-41ac-0faf-e063-6294a90a8ab52024-01-26WarningsExact identifier
application number: M012
Allergy ReliefALLERGY RELIEFGood Sensebb709377-7bb3-4931-a2b6-2443aee07c122024-01-26WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC721bfee2-0d3d-4d8b-beee-1ea83064d1c82024-01-23WarningsExact identifier
application number: M012
Sugar Free Cough Drops Honey LemonMENTHOLCardinal Health 110, Inc.fe90dc33-2815-8296-e053-6294a90ac1df2024-01-19WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLCardinal Health 110, Inc.fe91543e-a798-6399-e053-6394a90af5e52024-01-19WarningsExact identifier
application number: M012
Sugar Free Cough Drops Black CherryMENTHOLCardinal Health 110, Inc.fe90cf63-d286-fa5e-e053-6394a90a77592024-01-19WarningsExact identifier
application number: M012
Cough Drops Menthol Honey LemonCOUGH DROPS MENTHOLCardinal Health 110, Inc.fe5b3f6d-2a2d-f322-e053-6394a90aba042024-01-19WarningsExact identifier
application number: M012
Cough Drops MentholMENTHOL COUGH DROPSCardinal Health 110, Inc.fe5b557e-a689-a32c-e053-6294a90aadbd2024-01-19WarningsExact identifier
application number: M012
Cough Drops CherryCHERRY FLAVOR COUGH DROPSCardinal Health 110, Inc.fe5b5e57-1368-c62b-e053-6294a90ae82c2024-01-19WarningsExact identifier
application number: M012
Leader Zinc OxideZINC OXIDECardinal Health 110,Inc.4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d12024-01-18WarningsExact identifier
application number: M012
Cough and Congestion DM Sugar FreeDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINBest Choice (Valu Merchandisers Company)4656e60e-4733-45c1-bf55-d156e45085c62024-01-17WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLRugby Laboratories775f97c0-6f82-49a8-82ac-f1a73920c3ec2024-01-11WarningsExact identifier
application number: M012
SinuFrin NeilMedOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Incf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae2024-01-11WarningsExact identifier
application number: M012
SinuFrin Plus NeilMedOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals, Inc.99afe6a6-1350-49c6-9347-b7e531e359252024-01-11WarningsExact identifier
application number: M012
Childrens Tukol Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.85fe6f0f-41c8-44d3-a34a-355938da5f722024-01-11WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 110, LLC. DBA Leaderad437177-08eb-4811-883f-ac543d5bc58c2024-01-11WarningsExact identifier
application number: M012
Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYaf5053d8-ba02-4cdf-877f-8c1e368dafe02024-01-10WarningsExact identifier
application number: M012
HISTEXTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLCcc466d33-cf3e-4f1c-a794-6d3d79903adf2024-01-08WarningsExact identifier
application number: M012
HISTEX-DMDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC836d062c-29f0-4fd7-b65c-771a3bbd52c42024-01-08WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLA-S Medication Solutionse1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd2024-01-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2604562acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral SolutionPSN780907b8-34ba-4ec8-bcdf-b2a31bd111df5
2604562acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD780907b8-34ba-4ec8-bcdf-b2a31bd111df5
2604562acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG per 30 mL Oral SolutionSY780907b8-34ba-4ec8-bcdf-b2a31bd111df5
2604562APAP 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSY780907b8-34ba-4ec8-bcdf-b2a31bd111df5
2604635{1 (acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) / 1 (acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) } PackGPCK3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
26046351 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) PackPSN3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
2604562acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral SolutionPSN3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
1359455acetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
2604562acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
1359455acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
26046351 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) PackSY3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
26046351 nighttime (acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan HBr 1 MG/ML Oral Solution) / 1 daytime (acetaminophen 33.3 MG/ML / dextromethorphan HBr 1 MG/ML Oral Solution) PackSY3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
2604562acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG per 30 mL Oral SolutionSY3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
1359455acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral SolutionSY3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
1359455acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSY3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
2604562APAP 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSY3618ccf0-1f30-42e0-bb50-bfa45cf2b5834
1359455APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY3618ccf0-1f30-42e0-bb50-bfa45cf2b5834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-8205-0100067820501245.5 mL in 1 BOTTLE (0067-8205-01) 245.5 ml2022-06-27NoNoCurrent