FDA.reportPublic FDA data

Nighttime Cough-Kids

Product NDC
69676-0088
Requested package NDC
69676-0088-9
11-digit product format
696760088
Labeler code
69676
Product ID
69676-0088_3b51473d-2583-c018-e063-6294a90ad65e
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
SOLUTION
Route
ORAL
Labeler
Genexa
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-06
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2; 15 mg/10mL; mg/10mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Nighttime Cough-Kids
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE2 mg/10mL
CHLORPHENIRAMINE MALEATE15 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1111440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
024bb864-4214-1d8b-e063-6394a90aa573Available 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0088-9Nighttime Cough-Kids118 mL in 1 BOTTLESOLUTION1184
69676-0088-9Nighttime Cough-Kids1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0088NIGHTTIME COUGH-KIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) SOLUTION [GENEXA]3Current NDC, 2 package rows20250406_024bb864-4214-1d8b-e063-6394a90aa573.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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Childrens Benadryl ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCfc9181b9-c92d-493e-8d7c-4a4239c6c0922026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSN024bb864-4214-1d8b-e063-6394a90aa5734
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCD024bb864-4214-1d8b-e063-6394a90aa5734
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSY024bb864-4214-1d8b-e063-6394a90aa5734
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSY024bb864-4214-1d8b-e063-6394a90aa5734
2119625{1 (chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) } PackGPCK036fb529-3270-c649-e063-6394a90a2d742
21196251 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG in 5 mL Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG in 10 mL Oral Solution) PackPSN036fb529-3270-c649-e063-6394a90a2d742
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSN036fb529-3270-c649-e063-6394a90a2d742
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN036fb529-3270-c649-e063-6394a90a2d742
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCD036fb529-3270-c649-e063-6394a90a2d742
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD036fb529-3270-c649-e063-6394a90a2d742
21196251 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution) PackSY036fb529-3270-c649-e063-6394a90a2d742
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSY036fb529-3270-c649-e063-6394a90a2d742
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSY036fb529-3270-c649-e063-6394a90a2d742
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY036fb529-3270-c649-e063-6394a90a2d742
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY036fb529-3270-c649-e063-6394a90a2d742
2743069{1 (chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Suspension) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Suspension) } PackGPCK4bad39f1-86d4-b8a1-e063-6394a90a7a951
27430691 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG in 5 mL Oral Suspension) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG in 10 mL Oral Suspension) PackPSN4bad39f1-86d4-b8a1-e063-6394a90a7a951
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSN4bad39f1-86d4-b8a1-e063-6394a90a7a951
2743068chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG in 10 mL Oral SuspensionPSN4bad39f1-86d4-b8a1-e063-6394a90a7a951
2692303dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SuspensionPSN4bad39f1-86d4-b8a1-e063-6394a90a7a951
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCD4bad39f1-86d4-b8a1-e063-6394a90a7a951
2743068chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SuspensionSCD4bad39f1-86d4-b8a1-e063-6394a90a7a951
2692303dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SuspensionSCD4bad39f1-86d4-b8a1-e063-6394a90a7a951
27430691 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Suspension) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Suspension) PackSY4bad39f1-86d4-b8a1-e063-6394a90a7a951
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSY4bad39f1-86d4-b8a1-e063-6394a90a7a951
2743068chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG per 10 ML Oral SuspensionSY4bad39f1-86d4-b8a1-e063-6394a90a7a951
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSY4bad39f1-86d4-b8a1-e063-6394a90a7a951
2692303dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SuspensionSY4bad39f1-86d4-b8a1-e063-6394a90a7a951
2692303dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SuspensionSY4bad39f1-86d4-b8a1-e063-6394a90a7a951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69676-0088-9696760088091 BOTTLE in 1 CARTON (69676-0088-9) / 118 mL in 1 BOTTLE1 bottle2025-05-06NoNoCurrent