FDA.reportPublic FDA data

Kids Cough and Chest Congestion

Product NDC
69676-0037
11-digit product format
696760037
Labeler code
69676
Product ID
69676-0037_52ea129f-f95c-b9a3-e063-6394a90ac0be
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Genexa Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-08
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
100; 5 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
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
Kids Cough and Chest Congestion
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7ab2140-de09-158f-e053-2a95a90a25a0Available 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
69676-0037-9Kids Cough and Chest Congestion118 mL in 1 BOTTLE, PLASTICSUSPENSION11811
69676-0037-9Kids Cough and Chest Congestion1 in 1 CARTONSUSPENSION111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0037KIDS COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) SUSPENSION [GENEXA INC.]9Current NDC, Legacy NDC, 2 package rows20250210_a7ab2140-de09-158f-e053-2a95a90a25a0.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 29 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLL.N.K. International, Inc.db264d2f-bf81-4da2-8595-2bfa1e4ba2f12026-05-18WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c2026-05-15WarningsExact identifier
application number: M012
good neighbor pharmacy cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergenda91e6b6-32ff-44fd-afce-33ea9549554b2026-05-15WarningsExact identifier
application number: M012
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLC847cdee8-410f-4ff3-9245-976ed6f4c7762026-05-15WarningsExact identifier
application number: M012
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLCd3b2f300-d919-44cd-ab71-b74b5bdfd9772026-05-15WarningsExact identifier
application number: M012
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVERACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDSMEDWISE LIFESCIENCES INC.51d52ce4-98c4-2b9b-e063-6294a90ade442026-05-15WarningsExact identifier
application number: M012
Curewell Tussin DMDEXTROMETHORPHAN, GUAIFENESINRMT HEALTH LLC4fe9ad93-cdc4-b4df-e063-6294a90a90ae2026-05-15WarningsExact identifier
application number: M012
CounterAct Cough Drops Orchard CherryMENTHOLMelaleuca, Inc.6049842c-d763-4a91-a225-976ed74e16932026-05-15WarningsExact identifier
application number: M012
CounterAct Cough Drops Honey LemonMENTHOLMelaleuca, Inc.84ac3489-9d64-401f-ab78-715af4de54402026-05-15WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.51e03b5b-b05a-07c1-e063-6394a90ab2012026-05-15WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-Drowsy/DaytimeACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLRite Aid Corporation38d73a1e-ac78-4f67-9291-bb48ab80306e2026-05-15WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRWALMART INC.071615ba-f50a-4d2a-a358-43140bccce722026-05-14WarningsExact identifier
application number: M012
Severe Cold and Flu Nighttime DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Incd4bcfabb-a054-4f53-8dc9-d361a03558b82026-05-14WarningsExact identifier
application number: M012
Cough and Chest Congestion DM AdultDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy4444c05a-eba6-4633-b86f-34f455699fa92026-05-14WarningsExact identifier
application number: M012
Topcare Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTopco Associates LLCa88e5b8e-e6dd-4a1c-9628-5861d3205bdb2026-05-14WarningsExact identifier
application number: M012
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc69b24c67-cf4b-46d7-a44b-d1917cc876b12026-05-14WarningsExact identifier
application number: M012
GILTUSS DIABETIC EXGILTUSS DIABETIC EXGil Pharmaceutical Corpab7915e7-323a-4fe1-887a-a3bd3f0aac982026-05-13WarningsExact identifier
application number: M012
Giltuss EX Maximum Strength ExpectorantGILTUSS EX MAXIMUM STRENGTH EXPECTORANTGil Pharmaceutical Corp950db1ca-6936-47f8-a112-e3594d4c922c2026-05-13WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGILTUSS EX EXPECTORANTGil Pharmaceutical Corp3b363fb9-c4d3-446f-927c-f705ffc715b52026-05-13WarningsExact identifier
application number: M012
Giltuss HBP EX ExpectorantGILTUSS HBP EX EXPECTORANTGil Pharmaceutical Corp31bd6356-27cf-4188-8fd5-9cd9392021ca2026-05-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69676-0037-9696760037091 BOTTLE, PLASTIC in 1 CARTON (69676-0037-9) / 118 mL in 1 BOTTLE, PLASTIC2025-04-080000-00-00NoNoCurrent