FDA.reportPublic FDA data

Childrens Mucus Relief

Product NDC
63868-770
11-digit product format
638680770
Labeler code
63868
Product ID
63868-770_451da3de-0781-522d-e063-6394a90a3537
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Chain Drug Manufacturing Assn
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-10-19
Substance
GUAIFENESIN
Active strength
100 mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 Relief
Brand name suffix
Chest Congestion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310604Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
034d39c0-9aad-4dff-a158-a041b9f0504fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-770-042021-06-14C16284748780-1ba0f9c33-1395-a910-e053-dadaa90a0b85QC Quality Choice Children’s Mucus Relief Expectorant Grape Flavor 4 FL OZ (118mL)
63868-770-042021-01-29C16284748780-1ba0f9c33-1395-a910-e053-dadaa90a0b85QC Quality Choice Children’s Mucus Relief Expectorant Grape Flavor 4 FL OZ (118mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-770-04Childrens Mucus ReliefChest Congestion1 in 1 CARTONSOLUTION18
63868-770-04Childrens Mucus ReliefChest Congestion118 mL in 1 BOTTLESOLUTION1188

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-770-04ML - Milliliter63868-770755c4f32-8469-4f4d-a0d5-a3c78cae980412017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-770CHILDRENS MUCUS RELIEF CHEST CONGESTION (GUAIFENESIN) SOLUTION [CHAIN DRUG MANUFACTURING ASSN]7Current NDC, Legacy NDC, 2 package rows20241220_034d39c0-9aad-4dff-a158-a041b9f0504f.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 140 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength TYLENOL Cold Plus Flu Multi-Action DayACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC7d3266dc-879a-4d28-b8ea-74d238c3020a2024-11-07WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU SEVERE DAY/NIGHTACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ddb86a8-e34c-4a03-a60a-d3fedaf906082024-11-07WarningsExact identifier
application number: M012
Tylenol Cold Plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCce43e5c2-fe96-4462-882c-d7479318b33d2024-11-07WarningsExact identifier
application number: M012
TYLENOL SINUS PLUS HEADACHE DAYACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCe608d214-cc46-4a24-ac85-1040e36e74032024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLCe83f7911-22b4-4ffc-8f49-68f6acd2ebf52024-11-07WarningsExact identifier
application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.Kenvue Brands LLCf81d924e-10e9-0e9d-e053-6294a90a2ddf2024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8b516736-86ac-47cb-a0ec-038d4c3a00202024-11-07WarningsExact identifier
application number: M012
Tylenol Cold plus Flu plus Cough NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCe85e5eb9-3ecf-4784-999e-111e38e306f52024-11-07WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCef8a846d-4b29-4fd8-a683-fada04d0a2b92024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC9761c807-75a1-4498-a8c6-1f2b1c9ffde62024-11-07WarningsExact identifier
application number: M012
TYLENOL Cold Plus Mucus SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC24ac94e8-b223-424e-bcd2-9c027c8ff9ed2024-11-07WarningsExact identifier
application number: M012
PrimateneEPHEDRINE HYDROCHLORIDEFoundation Consumer Brands2170f081-c03f-47e8-bc63-4052c5e653fa2024-11-07WarningsExact identifier
application number: M012
Rompe Pecho Max Multi SymptomsACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESINEFFICIENT LABORATORIES INC938e4e47-d2d9-4b0d-bf88-e9f41b5019452024-11-07WarningsExact identifier
application number: M012
topcare sinus nasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCca1fefed-e9d7-430a-9da4-972b1a6fb7862024-11-07WarningsExact identifier
application number: M012
Leader Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderdd82a389-9ec5-4b3f-a9ea-1a56871ebd172024-11-07WarningsExact identifier
application number: M012
topcare day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC1a8e2e03-e11b-4da1-945b-e2caadea72432024-11-07WarningsExact identifier
application number: M012
SUDOGEST NASAL DECONGESTANTPSEUDOEPHEDRINE HCLA-S Medication Solutions09feb5f0-c22d-4a1b-97a0-d5767e5f77302024-11-07WarningsExact identifier
application number: M012
up and up childrens allergy meltsDIPHENHYDRAMINE HCLTarget Corporationf98d1d54-8e11-4bb1-825a-ab5447d378472024-11-07WarningsExact identifier
application number: M012
good sense severe day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company44130a1b-63cc-42ac-9590-fdf21a12d1642024-11-07WarningsExact identifier
application number: M012
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLCa5ff1134-8985-4585-8e61-a5fd5f60afeb2024-11-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN034d39c0-9aad-4dff-a158-a041b9f0504f8
310604guaifenesin 20 MG/ML Oral SolutionSCD034d39c0-9aad-4dff-a158-a041b9f0504f8
310604guaifenesin 100 MG per 5 ML Oral SolutionSY034d39c0-9aad-4dff-a158-a041b9f0504f8
310604guaifenesin 100 MG per 5 ML Oral SyrupSY034d39c0-9aad-4dff-a158-a041b9f0504f8
310604guaifenesin 200 MG per 10 ML Oral SolutionSY034d39c0-9aad-4dff-a158-a041b9f0504f8
310604guaifenesin 300 MG per 15 ML Oral SolutionSY034d39c0-9aad-4dff-a158-a041b9f0504f8
310604guaifenesin 400 MG per 20 ML Oral SolutionSY034d39c0-9aad-4dff-a158-a041b9f0504f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-770-04638680770041 BOTTLE in 1 CARTON (63868-770-04) / 118 mL in 1 BOTTLE1 bottle2015-10-190000-00-00NoNoCurrent