FDA.reportPublic FDA data

Childrens Mucus and Cough Relief

Product NDC
51316-552
11-digit product format
513160552
Labeler code
51316
Product ID
51316-552_90ee46e4-e631-4dd6-80cb-a54810dab4a7
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
CVS
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-28
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

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 Mucus and Cough Relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1dc17665-62ce-f7f5-e063-6294a90af851Available 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-552-03Childrens Mucus and Cough Relief118 mL in 1 BOTTLELIQUID1182
51316-552-03Childrens Mucus and Cough Relief1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-552CHILDRENS MUCUS AND COUGH RELIEF (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS]2Current NDC, 2 package rows20250130_1dc17665-62ce-f7f5-e063-6294a90af851.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 144 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tussin severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E B7cc2c136-d1b7-4658-99bb-73bb1d1402612024-11-04WarningsExact identifier
application number: M012
dg health tussinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Inca5d0ee70-d528-4a53-bf01-7bb13b364ed02024-11-04WarningsExact identifier
application number: M012
basic care tussin cf severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLCbba9a17d-eb87-46f3-acee-c9dd34e5bfd42024-11-04WarningsExact identifier
application number: M012
topcare tussin cf maxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCb553b7e6-933b-49e3-97d3-22a4643a04b92024-11-04WarningsExact identifier
application number: M012
dg health nasal originalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLCfb209752-705a-4bb0-9298-8b70357f39112024-11-02WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B3c301993-642a-487c-96a2-ebc4ef90dc882024-11-02WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1341744c-43c3-462b-b93c-1e46476fd9352024-11-01WarningsExact identifier
application number: M012
Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy43784616-1afd-4ff7-8fee-6ac389f616a22024-11-01WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLC28ef87e8-29e5-444d-b1f7-5c38a7f758d32024-11-01WarningsExact identifier
application number: M012
Good Sense Severe NightTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL. Perrigo Company0e3c36c9-d45b-41b9-891d-a42d854295f92024-11-01WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company7dc3941a-e5f8-4caa-bae5-6a0d075295cb2024-11-01WarningsExact identifier
application number: M012
DoloMax Cold CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBENARD INDUSTRIES INC520aee75-8b9a-4dcc-8970-75e122640e912024-10-31WarningsExact identifier
application number: M012
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutionsb6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe2024-10-31WarningsExact identifier
application number: M012
CareOne Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmerican Sales Company819d5c82-0240-4013-9904-c335bd65d03e2024-10-30WarningsExact identifier
application number: M012
Signature Care Nighttime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLSafeway9a0ad5d5-8fd9-468d-be2c-87c14d08b9342024-10-30WarningsExact identifier
application number: M012
Good Sense Severe NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL. Perrigo Companyf2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd22024-10-30WarningsExact identifier
application number: M012
dg health cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLDolgencorp, LLC81f3ac36-9bae-4f42-92a0-8a2e4bbd09842024-10-30WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLRite Aid Corporation9a71e8eb-4195-4694-bf3e-44f691ff2cef2024-10-30WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLH E Bfe4a95d2-6fb3-43fe-baec-6f22d19653232024-10-30WarningsExact identifier
application number: M012
NightTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger Company2c9ef0d7-3d5b-494a-8f06-9dd42110d78a2024-10-30WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN1dc17665-62ce-f7f5-e063-6294a90af8512
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1dc17665-62ce-f7f5-e063-6294a90af8512
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY1dc17665-62ce-f7f5-e063-6294a90af8512
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1dc17665-62ce-f7f5-e063-6294a90af8512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-552-03513160552031 BOTTLE in 1 CARTON (51316-552-03) / 118 mL in 1 BOTTLE1 bottle2025-01-28NoNoCurrent