FDA.reportPublic FDA data

Daytime and Nighttime High Blood Pressure Cold and Flu Liquid

Product NDC
51316-666
Requested package NDC
51316-666-07
11-digit product format
513160666
Labeler code
51316
Product ID
51316-666_3426bb4b-5798-7851-e063-6394a90a89a8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr and Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
KIT
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-21
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
Daytime and Nighttime High Blood Pressure Cold and Flu Liquid
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043400Internal RxNorm lookup
2604561Internal RxNorm lookup
2637756Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d13964a-8cc4-f3dc-e063-6394a90aa105Available 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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
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
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
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
51316-664-06Daytime and Nighttime High Blood Pressure Cold and Flu Liquid236 mL in 1 BOTTLELIQUID236 mL650 mg in 30mL2
51316-665-06Daytime and Nighttime High Blood Pressure Cold and Flu Liquid236 mL in 1 BOTTLELIQUID236 mL650 mg in 30mL2
51316-666-07Daytime and Nighttime High Blood Pressure Cold and Flu Liquid1 in 1 PACKAGEKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-666DAYTIME AND NIGHTTIME HIGH BLOOD PRESSURE COLD AND FLU LIQUID (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [CVS PHARMACY, INC.]2Current NDC, 3 package rows20250503_2d13964a-8cc4-f3dc-e063-6394a90aa105.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 114 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTINGCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRHaleon US Holdings LLCbecb4025-b63e-f2ea-9d11-d51fdf4e5c132025-06-04WarningsExact identifier
application number: M012
Diphenhydramine HCL STRAWBERRY FLAVORDIPHENHYDRAMINE HCLInnovida Pharmaeutique Corporation7eb709a5-c587-4f1d-bc2d-576d07a3a3bf2025-06-04WarningsExact identifier
application number: M012
Children Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLTARGET CORPORATION69d33f77-06e1-48fa-a516-892fdf11bb1c2025-06-03WarningsExact identifier
application number: M012
oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fd058e2b-5445-e416-e053-6394a90a611b2025-06-03WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.36b1a7e0-c8b9-0890-e063-6394a90ab13a2025-06-03WarningsExact identifier
application number: M012
COLD, FLU and SORE THROAT RELIEFACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MGBETTER LIVING BRANDS, LLC202d60a8-83da-5afc-e063-6394a90ad7792025-05-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLTARGET CORPORATIONf935341f-1e33-d78e-e053-6294a90a348e2025-05-30WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLAARNA USA INC.365bb414-8425-a900-e063-6394a90aa8872025-05-30WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEP & L Development, LLC8559be55-8b00-4353-8e26-b5dff2ada8062025-05-30WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalmart Inc.35da8429-1f83-9e81-e063-6294a90a35152025-05-23WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORP9dfef3dc-dbc8-659a-e053-2995a90a8c3b2025-05-21WarningsExact identifier
application number: M012
Adult TussinGUAIFENESINCamber Consumer Care896d2540-279a-4405-b176-acbff56303e52025-05-20WarningsExact identifier
application number: M012
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC37a88914-6234-4191-86f5-103c396c52af2025-05-20WarningsExact identifier
application number: M012
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLC1ea15426-4f3d-4a97-a590-6bd73bc6cbcd2025-05-19WarningsExact identifier
application number: M012
Quality Choice NasalOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION3833e781-f6ee-4c6d-8756-d8ea2293a1f22025-05-19WarningsExact identifier
application number: M012
Quality Choice Nasal Mist Severe CongestionOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONd45e99e5-ce66-4458-8d23-63a5dc7ae5092025-05-19WarningsExact identifier
application number: M012
Quality Choicel Nasal Mist Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION460f0cc1-6a85-4d79-af87-a94fd151769e2025-05-19WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC812a093f-cf83-4f7a-927a-1b5695be7f902025-05-19WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINSDA Laboratories, Inc.1fd16b06-0c3e-4a30-ae6a-7b1632189c202025-05-16WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLAkron Pharma Inc.79a6b8c7-0e81-4a46-a854-31f4490427092025-05-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637756{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } PackGPCK2d13964a-8cc4-f3dc-e063-6394a90aa1052
26377561 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) PackPSN2d13964a-8cc4-f3dc-e063-6394a90aa1052
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral SolutionPSN2d13964a-8cc4-f3dc-e063-6394a90aa1052
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN2d13964a-8cc4-f3dc-e063-6394a90aa1052
2604561acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSCD2d13964a-8cc4-f3dc-e063-6394a90aa1052
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD2d13964a-8cc4-f3dc-e063-6394a90aa1052
26377561 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) PackSY2d13964a-8cc4-f3dc-e063-6394a90aa1052
2604561acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral SolutionSY2d13964a-8cc4-f3dc-e063-6394a90aa1052
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY2d13964a-8cc4-f3dc-e063-6394a90aa1052
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral SolutionSY2d13964a-8cc4-f3dc-e063-6394a90aa1052
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY2d13964a-8cc4-f3dc-e063-6394a90aa1052
2604561APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSY2d13964a-8cc4-f3dc-e063-6394a90aa1052
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY2d13964a-8cc4-f3dc-e063-6394a90aa1052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-666-07513160666071 KIT in 1 PACKAGE (51316-666-07) * 236 mL in 1 BOTTLE (51316-665-06) * 236 mL in 1 BOTTLE (51316-664-06) 1 kit2025-04-21NoNoCurrent