FDA.reportPublic FDA data

Theraflu

Product NDC
0067-0112
11-digit product format
000670112
Labeler code
0067
Product ID
0067-0112_21636332-818b-26bf-e063-6394a90a1925
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-30
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
325; 12.5 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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
Brand name suffix
Severe Cold Relief Nighttime Soft Chews
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE12.5 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
2691689Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ba64bbe-7599-406a-9187-737c0f8c1c2aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0112-01TherafluSevere Cold Relief Nighttime Soft Chews20 in 1 BOTTLETABLET, CHEWABLE202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-0112THERAFLU SEVERE COLD RELIEF NIGHTTIME SOFT CHEWS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]2Current NDC, 1 package rows20241001_6ba64bbe-7599-406a-9187-737c0f8c1c2a.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 85 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores,Inc.,770c0e4f-0eed-4b8c-85a5-761b6a84db622025-12-02WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWAL-MART STORES INCa2a7e568-bff8-4818-a31d-7c2efa1859c32025-12-02WarningsExact identifier
application number: M012
DayTime Severe, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLETLil' Drug Store Products, Inc.44fa0193-2a19-bdc1-e063-6394a90a60e82025-12-02WarningsExact identifier
application number: M012
Nighttime Severe, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.44fb9958-d771-f4b3-e063-6294a90a91352025-12-02WarningsExact identifier
application number: M012
Quality Choice Mucus ReliefGUAIFENESINChain Drug Marketing Associationf1a73da7-0dbb-49bd-857e-7dd6bc11b63c2025-12-02WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 70000ac74be47-30f0-418b-bd07-502feaa9723f2025-12-01WarningsExact identifier
application number: M012
Walgreens High Blood Pressure Cold and FluACETAMINOPHEN, DEXTROMETHORPHANWALGREENS CO.bc83b55e-c3d8-460f-8ef9-ff7b2e4f72722025-12-01WarningsExact identifier
application number: M012
Walgreen High Blood Pressure Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREENS CO.f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a2025-12-01WarningsExact identifier
application number: M012
Walgreens Nighttime Kids Honey Cold Cough CongestionDOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS COc0f317cd-723d-47f2-b600-aaeae63994822025-12-01WarningsExact identifier
application number: M012
Walgreen Maximum Strength Severe Congestion and coughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALGREENS CO.b4abcb6d-f3e1-4d63-98cf-ff556ec423b62025-12-01WarningsExact identifier
application number: M012
Walgreens Daytime ChildrensCOUGH AND CHEST CONGESTIONWALGREENS CO.dd99675f-3860-42ef-999c-d9a3746a38c02025-12-01WarningsExact identifier
application number: M012
Adult Cough plus Chest Congestion DM with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINWALGREEN COMPANY5f5af13a-c2a3-4bbe-880e-9c57b36e92342025-12-01WarningsExact identifier
application number: M012
Walgreens Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWALGREEN COMPANYb2e08f4d-9753-4767-a8eb-3740dd1034cc2025-12-01WarningsExact identifier
application number: M012
WALGREENS Cold Cough and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.1e903034-942e-4c6e-9f96-eb097c2665802025-12-01WarningsExact identifier
application number: M012
Walgreens DAY and NIGHT PACKDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATEWALGREEN COcb87e57b-ff06-4973-9751-137c7021e2722025-12-01WarningsExact identifier
application number: M012
WALGREEN Multi Symptom Flu Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWALGREENS CO.b7b1d604-921d-4ae7-93de-dcf690d421b42025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLMeijer Distribution Inc235b2866-bbda-7148-e063-6394a90a898f2025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWhole Foods Market, INC.32352109-31dc-8e6f-e063-6294a90a2f922025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.323347c3-d51a-4976-e063-6294a90a952e2025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWALGREEN COMPANY2969ba8f-c477-222a-e063-6394a90af7032025-12-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691689acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG Chewable TabletPSN6ba64bbe-7599-406a-9187-737c0f8c1c2a2
2691689acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable TabletSCD6ba64bbe-7599-406a-9187-737c0f8c1c2a2
2691689APAP 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable TabletSY6ba64bbe-7599-406a-9187-737c0f8c1c2a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0067-0112-010006701120120 TABLET, CHEWABLE in 1 BOTTLE (0067-0112-01) 2024-09-30NoNoCurrent