FDA.reportPublic FDA data

Childrens Daytime Mucus

Product NDC
0363-9358
11-digit product format
003639358
Labeler code
0363
Product ID
0363-9358_6803d077-867b-4d8e-981b-5d2c40223a60
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
CHEWABLE GEL
Route
ORAL
Labeler
Walgreens
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
10 mg/1
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
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
Childrens Daytime Mucus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2683424Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a55b7e1-1054-421e-847e-5e4d90d1aebbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9358-16Childrens Daytime Mucus16 in 1 BOTTLE, PLASTICCHEWABLE GEL169
0363-9358-16Daytime Nighttime Chewable16 in 1 BOTTLE, PLASTICCHEWABLE GEL1610 mg8

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 104 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique Medi-MucusDEXTROMETHORPHAN HBR, GUAIFENESINUnifirst First Aid Corporationf3bb862a-9cb8-f644-e053-2a95a90a5f4f2025-09-08WarningsExact identifier
application number: M012
Physicians Care Cough and Sore ThroatMENTHOLAcme United Corporation4e02223d-f34b-333e-e054-00144ff8d46c2025-09-08WarningsExact identifier
application number: M012
Physicians Care Non-Drowsy Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAcme United186ec543-1f23-75d6-e063-6294a90a46b92025-09-08WarningsExact identifier
application number: M012
PhysiciansCare Sinus Non-DrowsyPHENYLEPHRINE HCLAcme United Corporationa6daf3ef-f386-4de4-b38e-d0b90c9ae62b2025-09-08WarningsExact identifier
application number: M012
PhysiciansCare Allergy Multi-Symptom ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEAcme United Corporationfd101c27-6ba9-4cd3-baec-a354504c37a02025-09-08WarningsExact identifier
application number: M012
Green Guard Honey Lemon Cough DropMENTHOL 8.6 MGUnifirst First Aid Corporation8a94f090-61d6-4909-e053-2995a90aee382025-09-08WarningsExact identifier
application number: M012
Green Guard Cough Drop ReliefMENTHOLUnifirst First Aid Corporation0fc4cb11-8ff9-4eff-9588-c73eef4e01372025-09-08WarningsExact identifier
application number: M012
Multi-Symptom Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,Unifirst First Aid Corporatione6ea6faf-baff-a130-e053-2a95a90a085a2025-09-08WarningsExact identifier
application number: M012
MEDIQUE Medikoff DropsMENTHOLUnifirst First Aid Corporation0d6b4443-16a1-4851-bb03-d7407167551d2025-09-08WarningsExact identifier
application number: M012
Medique Sugar Free Medikoff DropsMENTHOLUnifirst First Aid Corporation92d13e19-4e7b-4565-970e-504abf02579a2025-09-08WarningsExact identifier
application number: M012
Medique at Home DiphenDIPHENHYDRAMINE HCLUnifirst First Aid Corporationb56d1966-efd7-56eb-e053-2995a90a89b52025-09-08WarningsExact identifier
application number: M012
Medique ChlorphenCHLORPHENIRAMINE MALEATEUnifirst First Aid Corporationb3d5d161-8d4c-f1bb-e053-2a95a90a5bc52025-09-08WarningsExact identifier
application number: M012
Crane Safety Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDECrane Safety LLC968baa85-ce0e-0c3d-e053-2995a90ac03a2025-09-08WarningsExact identifier
application number: M012
Thompson Cherry Cough DropsMENTHOLThompson Safety LLCc948f5b0-8491-6f9f-e053-2995a90a55fa2025-09-08WarningsExact identifier
application number: M012
Medique Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione64c283b-0efa-0bfd-e053-2a95a90ab71d2025-09-08WarningsExact identifier
application number: M012
Daytime Nighttime Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATEWalgreensa99fdd49-0160-4a82-983b-fa56ab38ae762025-09-08WarningsExact identifier
application number: M012
Dye Free Wal Dryl Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEWalgreens53e6f72d-15a4-4efe-8b1f-5753fed53df82025-09-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreens40bfd631-51a4-4684-9ba0-a365d61da9bc2025-09-08WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreensf796ce1f-3077-4a0d-a41a-249c345ddb5f2025-09-08WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc6ccbd537-2264-4b3c-804e-3d3ea5368a5f2025-09-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2683424dextromethorphan hydrobromide 10 MG Chewable TabletPSN7a55b7e1-1054-421e-847e-5e4d90d1aebb9
2683424dextromethorphan hydrobromide 10 MG Chewable TabletSCD7a55b7e1-1054-421e-847e-5e4d90d1aebb9
2683424dextromethorphan HBr 10 MG Chewable TabletSY7a55b7e1-1054-421e-847e-5e4d90d1aebb9
2683425{1 (dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Chewable Tablet) / 1 (dextromethorphan hydrobromide 10 MG Chewable Tablet) } PackGPCK9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c68
26834251 daytime (dextromethorphan HBr 10 MG Chewable Tablet) / 1 nighttime (dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Chewable Tablet) PackPSN9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c68
2683423dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Chewable TabletPSN9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c68
2683424dextromethorphan hydrobromide 10 MG Chewable TabletPSN9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c68
2683423dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Chewable TabletSCD9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c68
2683424dextromethorphan hydrobromide 10 MG Chewable TabletSCD9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c68
26834251 daytime (dextromethorphan HBr 10 MG Chewable Tablet) / 1 nighttime (dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Chewable Tablet) PackSY9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c68
2683423dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Chewable TabletSY9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c68
2683424dextromethorphan HBr 10 MG Chewable TabletSY9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9358-160036393581616 CHEWABLE GEL in 1 BOTTLE, PLASTIC (0363-9358-16) 16 chewable gel2026-04-30NoNoCurrent