FDA.reportPublic FDA data

Codeine-Guaifenesin

Product NDC
69367-272
11-digit product format
693670272
Labeler code
69367
Product ID
69367-272_447eca2f-cbca-4ae6-bcd9-dfac47105319
Type
HUMAN OTC DRUG
Nonproprietary name
Codeine Phosphate and Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-15
Substance
CODEINE PHOSPHATE; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA schedule
CV
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
Codeine-Guaifenesin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CODEINE PHOSPHATE10 mg/5mL
GUAIFENESIN100 mg/5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
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
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-272-04Codeine-Guaifenesin118 mL in 1 BOTTLESOLUTION1186
69367-272-16Codeine-Guaifenesin473 mL in 1 BOTTLESOLUTION4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-272CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [WESTMINSTER PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20250515_3da3efd7-e278-4d79-9130-eef3992097e4.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 142 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good neighbor pharmacy adult tussin DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergenced71993-f535-4e28-bc1d-3fcb7d86e9b72024-11-08WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS Pharmacy2f1dc8f8-79c5-4724-99aa-a55330ed9d5f2024-11-08WarningsExact identifier
application number: M012
good sense day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company4ac6b64a-8214-4b03-8aa5-0d3199cf0b722024-11-08WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINH E B1dd9afb6-9b58-4274-a557-900a0cb235242024-11-08WarningsExact identifier
application number: M012
DG health sinus severeOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLC7abaa912-be8b-463c-8818-104e79b335392024-11-07WarningsExact identifier
application number: M012
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN3da3efd7-e278-4d79-9130-eef3992097e46
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3da3efd7-e278-4d79-9130-eef3992097e46
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3da3efd7-e278-4d79-9130-eef3992097e46
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSNc26da6e0-ab1c-46c2-acf5-0074958c03cd5
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDc26da6e0-ab1c-46c2-acf5-0074958c03cd5
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYc26da6e0-ab1c-46c2-acf5-0074958c03cd5
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSNe9705358-3522-46b3-a860-afb9141968b43
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDe9705358-3522-46b3-a860-afb9141968b43
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYe9705358-3522-46b3-a860-afb9141968b43
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d2
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSNc6a42780-9977-708f-e053-2a95a90a07e62
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d2
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDc6a42780-9977-708f-e053-2a95a90a07e62
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d2
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYc6a42780-9977-708f-e053-2a95a90a07e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-272-0469367027204118 mL in 1 BOTTLE (69367-272-04) 118 ml2020-07-150000-00-00NoNoCurrent
69367-272-1669367027216473 mL in 1 BOTTLE (69367-272-16) 473 ml2020-07-150000-00-00NoNoCurrent