FDA.reportPublic FDA data

Overnight Cold and Flu

Product NDC
0363-6980
11-digit product format
003636980
Labeler code
0363
Product ID
0363-6980_446afe14-2e44-2cf8-e063-6394a90af70e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Triprolidine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
WALGREENS CO
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-28
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength
650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes
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
Overnight Cold and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
TRIPROLIDINE HYDROCHLORIDE2.5 mg/20mL

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
YAN7R5L890Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2173667Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
807e8ace-2901-4c5f-96dc-04c755484b95Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6980-06Overnight Cold and Flu180 mL in 1 BOTTLESOLUTION1807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6980OVERNIGHT COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL) SOLUTION [WALGREENS CO]6Current NDC, Legacy NDC, 1 package rows20241113_807e8ace-2901-4c5f-96dc-04c755484b95.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 10 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Inc.6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f2024-12-02WarningsExact identifier
application number: M010
Diphenhydramine HClDIPHENHYDRAMINE HCLCVS Pharmacy, Inc.6dd802ec-fc26-3913-e053-2a91aa0ad05d2024-12-02WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC236ff457-0ec1-9c49-e063-6394a90a707a2024-11-26WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.50d74111-6d1b-4681-a264-f7e5503202592024-11-25WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.efb05387-72c0-4643-8541-b7990c202ce62024-11-25WarningsExact identifier
application number: M010
Nighttime Sleep Aid, 24-7 Life BY 7-ELEVEN, 6ozDIPHENHYDRAMINE HCL SOLUTIONLil' Drug Store Products, Inc.2781fc28-8a7d-d0fa-e063-6394a90ac7932024-11-22WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.7830ce18-908a-4f86-a238-8c31cfe47ce62024-11-21WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.f8de6605-4a0a-492d-beb5-f414ce8bfb0e2024-11-20WarningsExact identifier
application number: M010
Nighttime SLEEP AIDDIPHENHYDRAMINE HCL 50MGPuraCap Pharmaceutical LLC272a7138-2a97-8e62-e063-6394a90a1af12024-11-18WarningsExact identifier
application number: M010
ZzzQuilDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.0b2777be-85d4-443d-b65f-6750e0ba97ba2024-11-18WarningsExact identifier
application number: M010
RiteAid Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENRITE AID CORPORATION54fc0893-9702-4849-a702-3e84dc9ead032024-10-30WarningsExact identifier
application number: M010
Rite Aid Nighttime Sleep Aid Non Habit FormingDIPHENHYDRAMINE HYDROCHLORIDERITE AID CORPORATION59ba6824-fa6c-4b3f-9f1f-ea194766c8a12024-10-30WarningsExact identifier
application number: M010
GOOD REMEDIES Nighttime Sleep Aid CapletsDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.24fba735-cedf-9d15-e063-6394a90af8732024-10-29WarningsExact identifier
application number: M010
Premier Value Nighttime Sleep-Aid Liquid Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Consortium6d24b6e1-7959-47c6-a09b-c7e00a4374952024-10-28WarningsExact identifier
application number: M010
NytolDIPHENHYDRAMINE HCLMedtech Products Inc.c81d018a-0170-4396-81e9-2e13a53f868a2024-10-25WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.2ab3852d-53a4-411b-a9ad-3ef88ab3ee872024-10-23WarningsExact identifier
application number: M010
nitetime sleep aidDIPHENHYDRAMINE HCLMeijer Distribution Inc43184abd-2525-402a-a388-85af2e5c13ad2024-10-17WarningsExact identifier
application number: M010
Good Sense Sleep TimeDIPHENHYDRAMINE HCLL. Perrigo Company164200a9-b1f8-44c9-8598-a7dff5020e9d2024-10-16WarningsExact identifier
application number: M010
Equaline Night Time Sleep AidDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI6d34ee3e-3d61-481e-98d6-acfa066e42472024-10-16WarningsExact identifier
application number: M010
basic care nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLC027de5ea-5c07-4960-8a98-8cf2c0e54a922024-10-16WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2173667acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN807e8ace-2901-4c5f-96dc-04c755484b957
2173667acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD807e8ace-2901-4c5f-96dc-04c755484b957
2173667acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY807e8ace-2901-4c5f-96dc-04c755484b957
2173667APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY807e8ace-2901-4c5f-96dc-04c755484b957

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-6980-0600363698006180 mL in 1 BOTTLE (0363-6980-06) 180 ml2020-01-280000-00-00NoNoCurrent