FDA.reportPublic FDA data

Nighttime Childrens Multi Symptoms

Product NDC
49035-545
11-digit product format
490350545
Labeler code
49035
Product ID
49035-545_42355715-736c-9a09-e063-6394a90af1a7
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate and Dextromethorphan Hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
WAL-MART STORES,INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-30
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2; 15 mg/15mL; mg/15mL
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
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
Nighttime Childrens Multi Symptoms
Brand name suffix
Cold and Cough Multi-Symptom Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE15 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1114361Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
68a68574-0fcb-4569-be57-d9aee5f62beaAvailable 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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-545-08Nighttime Childrens Multi SymptomsCold and Cough Multi-Symptom Relief236 mL in 1 BOTTLE, PLASTICSOLUTION2367

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-545NIGHTTIME CHILDRENS MULTI SYMPTOMS COLD AND COUGH MULTI-SYMPTOM RELIEF (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [WAL-MART STORES,INC.]6Current NDC, Legacy NDC, 1 package rows20241116_68a68574-0fcb-4569-be57-d9aee5f62bea.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 63 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zicam Extreme Congestion ReliefOXYMETAZOLINE HYDROCHLORIDEChurch & Dwight Co., Inc.ccada339-656c-a461-e053-2a95a90a34792025-12-31WarningsExact identifier
application number: M012
ED A-HIST DMDEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEEDWARDS PHARMACEUTICALS, INC.e0e2b117-62bc-4132-9f7c-fe2a912052b12025-12-31WarningsExact identifier
application number: M012
Bio-Z-CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAdvanced Generic Corporation05e70eab-1467-4b09-991e-ef03f222e0212025-12-31WarningsExact identifier
application number: M012
Altipres-BBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAlternative Pharmacal Corporationfd00c41d-0580-4177-afaa-60bb12ca5a092025-12-31WarningsExact identifier
application number: M012
Ninjacof-DCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDECenturion Labs, LLC5188aa20-41f1-4998-81e1-f4de055874bc2025-12-31WarningsExact identifier
application number: M012
Llorens Care Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.4743e562-1217-50ab-e063-6394a90af88d2025-12-31WarningsExact identifier
application number: M012
Llorens Care TussinGUAIFENESINLlorens Pharmaceutical International Division, Inc.474459c1-bfd7-dec7-e063-6394a90ac18d2025-12-31WarningsExact identifier
application number: M012
Geri Care Tussin CF MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINGERI-CARE PHARMACEUTICAL CORP4744669c-7f33-e35f-e063-6394a90a79b72025-12-31WarningsExact identifier
application number: M012
Geri-TussinGUAIFENESINGeri-Care Pharmaceuticals, Corp65545ca3-4e93-4b59-9e17-4742e086e8e72025-12-31WarningsExact identifier
application number: M012
GeriCare Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINGERI-CARE PHARMACEUTICALS, CORP47451cd8-7aab-90e2-e063-6394a90ad1b72025-12-31WarningsExact identifier
application number: M012
Curewell TussinGUAIFENESINRMT HEALTH LLC47455587-5074-e70d-e063-6294a90a78bb2025-12-31WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBestco Inc.77e25027-3c96-21fa-e053-2991aa0a1f312025-12-31WarningsExact identifier
application number: M012
Puregen Labs Allergy ReliefDIPHENHYDRAMINE HCLAdvanced Rx LLC4745d4f9-bbdf-a4a6-e063-6294a90a15b22025-12-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2a46ea9b-29e9-5197-e063-6394a90abc732025-12-31WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLBestco Inc.77e50410-306d-b2fb-e053-2a91aa0af3c52025-12-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONe086a6d2-f664-454e-9524-f656bfbf45df2025-12-31WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLBestco Inc.77f45efb-8ee0-1186-e053-2991aa0a98842025-12-31WarningsExact identifier
application number: M012
Conex PediatricDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a46af43-ef36-e14e-e063-6394a90a82852025-12-31WarningsExact identifier
application number: M012
ConexDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a343656-ac6d-8b20-e063-6294a90ab3192025-12-31WarningsExact identifier
application number: M012
Dologesic NFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division974fc0d5-7a99-46fb-af38-b91240f728fa2025-12-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114361chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN68a68574-0fcb-4569-be57-d9aee5f62bea7
1114361chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD68a68574-0fcb-4569-be57-d9aee5f62bea7
1114361chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSY68a68574-0fcb-4569-be57-d9aee5f62bea7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-545-0849035054508236 mL in 1 BOTTLE, PLASTIC (49035-545-08) 236 ml2020-03-300000-00-00NoNoCurrent