FDA.reportPublic FDA data

Theraflu Severe Cold Relief Daytime Berry Burst

Product NDC
0067-6800
11-digit product format
000676800
Labeler code
0067
Product ID
0067-6800_77b6db34-5ac4-46a5-9d6d-1c4cc83a9ba9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine Hydrochloride
Dosage form
POWDER
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-20
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [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 Severe Cold Relief Daytime Berry Burst
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659967Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebbb2f4b-ba84-40ad-96f6-60225119a33bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0067-6800-022024-01-30C16284748780-11030e365-377c-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-6800-02Theraflu Severe Cold Relief Daytime Berry Burst6 in 1 CARTONPOWDER63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-6800-02EA - Each0067-6800a77a4080-ed09-43f5-ab5c-0dd6b78f56c112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-6800THERAFLU SEVERE COLD RELIEF DAYTIME BERRY BURST (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE) POWDER [HALEON US HOLDINGS LLC]3Current NDC, 1 package rows20240229_ebbb2f4b-ba84-40ad-96f6-60225119a33b.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 81 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Basic Care Honey Lemon Cough DropsMENTHOLAmazon.comc0937b13-f679-a764-e053-2a95a90abf892025-12-05WarningsExact identifier
application number: M012
Basic Care SF Menthol Cough DropsMENTHOLAmazon.comc0946295-7cf0-1bd8-e053-2a95a90af5af2025-12-05WarningsExact identifier
application number: M012
Basic Care SF Honey Lemon Cough DropsMENTHOLAmazon.comcf82fb0b-1b4d-def1-e053-2995a90a6fd92025-12-05WarningsExact identifier
application number: M012
G-DOLOGENACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEKramer Novis7a4e1d64-2510-405f-a1dc-e02a803b6fbd2025-12-05WarningsExact identifier
application number: M012
Quality Choice Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEChain Drug Manufacturing Assnce658dd5-b683-436e-b16b-0c06f6f87fd92025-12-04WarningsExact identifier
application number: M012
Quality Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa87ba15f-b5a9-4983-a721-ca7f705aea862025-12-04WarningsExact identifier
application number: M012
Quality ChoicePHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa12e2e66-d2f3-47a6-a915-a309ae828d272025-12-04WarningsExact identifier
application number: M012
Childrens Mucus Relief Chest CongestionGUAIFENESINChain Drug Manufacturing Assn034d39c0-9aad-4dff-a158-a041b9f0504f2025-12-04WarningsExact identifier
application number: M012
Quality ChoiceOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONd01b8fb6-1ddf-4901-bda6-ae608e94a6a42025-12-04WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEChain Drug Manufacturing Assn06822a28-3f82-471d-8db5-c5981b263a032025-12-04WarningsExact identifier
application number: M012
QUALITY CHOICEPHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION14596551-dd82-46b3-8eb8-e69efaea105b2025-12-04WarningsExact identifier
application number: M012
Daytime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Incfd5c20ed-5520-4db0-bfd4-995f043af2a42025-12-04WarningsExact identifier
application number: M012
Afrin OriginalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.89c165ba-3ad5-49b5-a5bb-423dc8e15bad2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Powerfast Fizz NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a2b30c27-b836-f09f-e053-2995a90ac3832025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast FizzASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.a37c9d9d-52db-23ff-e053-2995a90a8f762025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Cough PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night PowermaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.a68df74d-dd26-3ae9-e053-2995a90a08d62025-12-04WarningsExact identifier
application number: M012
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.55662ada-677e-4048-9529-5bca440763162025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.b13d5132-cb91-3cf6-e053-2a95a90aa47c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast FizzCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.bd97e91f-1ae1-379c-e053-2995a90acfdd2025-12-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNebbb2f4b-ba84-40ad-96f6-60225119a33b3
1659967acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDebbb2f4b-ba84-40ad-96f6-60225119a33b3
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionSYebbb2f4b-ba84-40ad-96f6-60225119a33b3
1659967APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYebbb2f4b-ba84-40ad-96f6-60225119a33b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-6800-02000676800026 POWDER in 1 CARTON (0067-6800-02) 6 powder2022-01-20NoNoCurrent