FDA.reportPublic FDA data

Walgreens Daytime

Product NDC
0363-7550
11-digit product format
003637550
Labeler code
0363
Product ID
0363-7550_44e1abdc-759f-5b5d-e063-6294a90a698f
Type
HUMAN OTC DRUG
Nonproprietary name
Cough and Chest Congestion
Dosage form
LIQUID
Route
ORAL
Labeler
WALGREENS CO.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-16
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5; 100 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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

Additional Listing Data#

Finished product
Yes
Brand name base
Walgreens Daytime
Brand name suffix
Childrens
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1020138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-7550-042025-12-01C16284748780-1f386c64a-0a68-0266-e053-dadaa90a7c1aWalgreens Children’s Cough and Chest Congestion
0363-7550-042025-01-30C16284748780-1f386c64a-0a68-0266-e053-dadaa90a7c1aWalgreens Children’s Cough and Chest Congestion
0363-7550-042023-01-30C16284748780-1f386c64a-0a68-0266-e053-dadaa90a7c1aWalgreens Children’s Cough and Chest Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7550-04Walgreens DaytimeChildrens118 mL in 1 BOTTLELIQUID1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7550WALGREENS DAYTIME CHILDRENS (COUGH AND CHEST CONGESTION) LIQUID [WALGREENS CO.]5Current NDC, Legacy NDC, 1 package rows20231027_dd99675f-3860-42ef-999c-d9a3746a38c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNdd99675f-3860-42ef-999c-d9a3746a38c06
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDdd99675f-3860-42ef-999c-d9a3746a38c06
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYdd99675f-3860-42ef-999c-d9a3746a38c06
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYdd99675f-3860-42ef-999c-d9a3746a38c06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-7550-0400363755004118 mL in 1 BOTTLE (0363-7550-04) 118 ml2019-07-160000-00-00NoNoCurrent