FDA.reportPublic FDA data

Theraflu Relief Max Strength

Product NDC
51316-549
11-digit product format
513160549
Labeler code
51316
Product ID
51316-549_886c356e-8c85-40c3-a154-ce68fa85d0d9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate and Dextromethophan HBr
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
CVS PHARMACY
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-17
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE
Active strength
1000; 30; 4 mg/1; mg/1; mg/1
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
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
Theraflu Relief Max Strength
Brand name suffix
Nighttime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN1000 mg/1
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1
CHLORPHENIRAMINE MALEATE4 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
V1Q0O9OJ9ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2636658Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b567234-1da9-4e10-a427-877eea2be1c1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
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
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
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00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
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22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
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7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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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
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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c35d1ac8-8885-2ee1-6c52-5a715b242c00Product 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
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-549-06Theraflu Relief Max StrengthNighttime1 in 1 PACKETPOWDER, FOR SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-549THERAFLU RELIEF MAX STRENGTH NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR) POWDER, FOR SOLUTION [CVS PHARMACY]2Current NDC, 1 package rows20241124_4b567234-1da9-4e10-a427-877eea2be1c1.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 7 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANYe96ec4d4-53b9-4636-a58c-1a5923a021ad2025-10-31WarningsExact identifier
application number: M010
GOODNOW SLEEP AIDDIPHENHYDRAMINE HCLGobrands, Inc7d821b7d-6a31-4ff7-b587-51907ba626582025-10-29WarningsExact identifier
application number: M010
SominexDIPHENHYDRAMINE HYDROCHLORIDEMedtech Products Inc.f7858ecf-8498-4465-85d8-3e78147375732025-10-23WarningsExact identifier
application number: M010
Sominex MaxDIPHENHYDRAMINE HCLMedtech Products Inc.e8f6991f-c47a-4d12-934b-04fdf092dac32025-10-23WarningsExact identifier
application number: M010
equate NIGHTTIME Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.3d3f2e0c-e141-d49f-e063-6394a90ad0e62025-10-21WarningsExact identifier
application number: M010
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH6fe34d05-84a4-4254-aea6-77b52122ea182025-10-14WarningsExact identifier
application number: M010
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH68c79c47-11bf-4b51-ace0-723cac7a46202025-10-14WarningsExact identifier
application number: M010
InstaRelief Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEDXM Pharmacuetical, Inc.e0459e71-32dd-4715-b103-bb14db42c5f32025-10-06WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)1eb2e4d7-1572-4c0c-888b-342831298cad2025-10-03WarningsExact identifier
application number: M010
AXIV - VroZzzDIPHENHYDRAMINE HYDROCHLORIDEVivunt Pharma LLC131a60cf-02ec-5a5b-e063-6294a90abd1f2025-09-17WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)485ce8ae-c2b7-462f-9c08-8594cd121f0c2025-09-11WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEWALGREENS35b78063-e717-2ccb-e063-6394a90a18eb2025-09-04WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationded84160-8f6a-4ad1-93be-efbf3a6c3b8f2025-09-03WarningsExact identifier
application number: M010
QUALITY CHOICE NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)3ce00c99-1a9b-41f1-a99a-35e03730dff02025-08-23WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBJWC (Berkley & Jensen / BJ's)2f476647-5727-3443-e063-6394a90afd3f2025-08-19WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBJWC (Berkley & Jensen / BJ's)2f477706-0ce2-97b0-e063-6294a90a5c8e2025-08-19WarningsExact identifier
application number: M010
Nighttime Sleep AidNIGHTTIME SLEEP AIDAllegiant Health407ff0ee-41a3-4dea-95c8-556f664e115e2025-08-06WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLH E B1069961c-ed3b-471f-a632-81024c37dbd92025-08-04WarningsExact identifier
application number: M010
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC2ea0b2cf-f055-11f6-e063-6394a90a53642025-08-01WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLGood Sense (Geiss, Destin & Dunn, Inc.)135482d0-5264-4c81-b43b-8fc931bb02e82025-07-30WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Powder for Oral SolutionPSN4b567234-1da9-4e10-a427-877eea2be1c13
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSCD4b567234-1da9-4e10-a427-877eea2be1c13
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral SolutionSY4b567234-1da9-4e10-a427-877eea2be1c13
2636658APAP 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSY4b567234-1da9-4e10-a427-877eea2be1c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-549-06513160549061 POWDER, FOR SOLUTION in 1 PACKET (51316-549-06) 2023-04-17NoNoCurrent