FDA.reportPublic FDA data

Guaifenesin and Codeine Phosphate

Product NDC
0121-1775
11-digit product format
001211775
Labeler code
0121
Product ID
0121-1775_2175415b-f07e-50a6-e063-6394a90acabe
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Codeine Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-10-01
Substance
GUAIFENESIN; CODEINE PHOSPHATE
Active strength
100; 10 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
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
Guaifenesin and Codeine Phosphate
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GSL05Y1MN6Internal 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
995868Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
88d0994c-4270-4408-8837-bd97510b2118Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0121-1775-002022-03-28Guaifenesin and Codeine Phosphate
0121-1775-102022-03-28Guaifenesin and Codeine Phosphate
0121-1775-002022-01-28Guaifenesin and Codeine Phosphate
0121-1775-102022-01-28Guaifenesin and Codeine Phosphate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1775-00Guaifenesin and Codeine Phosphate10 in 1 TRAYSOLUTION1011
0121-1775-00Guaifenesin and Codeine Phosphate10 in 1 CASESOLUTION1011
0121-1775-05Guaifenesin and Codeine Phosphate5 mL in 1 CUP, UNIT-DOSESOLUTION511
0121-1775-10Guaifenesin and Codeine Phosphate10 in 1 CASESOLUTION1011
0121-1775-10Guaifenesin and Codeine Phosphate10 in 1 TRAYSOLUTION1011
0121-1775-40Guaifenesin and Codeine Phosphate4 in 1 CASESOLUTION411
0121-1775-40Guaifenesin and Codeine Phosphate10 in 1 TRAYSOLUTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1775-00ML - Milliliter0121-1775fdafec21-258c-4805-9ff7-66930e2484d412017-08-11
0121-1775-05ML - Milliliter0121-17754eac12b0-97b2-4ef1-bef3-888760717dfa12012-07-24
0121-1775-10ML - Milliliter0121-1775fe8b87eb-c801-465e-91f8-5a36471e2a4312012-07-24
0121-1775-40ML - Milliliter0121-177583b2dba4-69f5-4ad4-ad62-88c4211f618412024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN6GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [APOTHECA, INC]1
GuaifenesinACTIVE INGREDIENT495W7451VQGUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
GuaifenesinACTIVE INGREDIENT495W7451VQGUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [APOTHECA, INC]1
CodeineACTIVE MOIETYQ830PW7520GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JGUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [APOTHECA, INC]1
GuaifenesinACTIVE MOIETY495W7451VQGUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQGUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [APOTHECA, INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [APOTHECA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1775GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC]11Current NDC, Legacy NDC, 7 package rows20240907_88d0994c-4270-4408-8837-bd97510b2118.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 18 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SINUS AND HEADACHEACETAMINOPHEN, PHENYLEPHRINE HCLRite Aid Corporationefaf3be1-ab39-45f7-a45c-7fea8705c8d02026-07-10WarningsExact identifier
application number: M012
Equate Daytime Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.f847d9f2-aa47-4bbe-8f06-19356c6373982026-07-10WarningsExact identifier
application number: M012
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLTopco Associates, LLC2a80fba9-5e30-4ec0-bd8e-8957c0654b6c2026-07-10WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50230cad-3d04-8882-e063-6294a90acf3c2026-07-09WarningsExact identifier
application number: M012
Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLRugby Laboratoriesfc42e97d-1224-4d29-a55d-1a1885e0bf8f2026-07-09WarningsExact identifier
application number: M012
Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader7418d92d-a540-40d6-91d0-b7eb1f87f8ff2026-07-08WarningsExact identifier
application number: M012
DG HEALTH COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d2026-07-08WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLTopco Associates, LLCbfcabe02-7961-4407-a748-8cd0877313982026-07-08WarningsExact identifier
application number: M012
Aller-chlorCHLORPHENIRAMINE MALEATERugby Laboratories04ca3806-72be-47d4-9fea-5b0dee0876832026-07-08WarningsExact identifier
application number: M012
nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED24c22c9f-0c2f-46dc-850e-ed05f00d3e952026-07-08WarningsExact identifier
application number: M012
NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.0e65c5d1-a18b-452c-9be6-8d44d34577e92026-07-08WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATECardinal Health 110, LLC. DBA Leaderaaecfda5-1a50-4d8a-9909-7153c1a22bda2026-07-08WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7cb9f378-5d64-475f-bf26-4058ba6c15b42026-07-08WarningsExact identifier
application number: M012
DG HEALTH DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Incf174d08e-3335-4cc9-8766-4070f18c4f312026-07-08WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESIN 400 MGHealth Pharma USA LLCd60a3e9d-e88e-3b19-e053-2995a90a3e8d2026-07-07WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLCd38f47ea-7fda-170b-e053-2995a90adc822026-07-07WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsExact identifier
application number: M012
Cold and Flu Severe Day Time / Night TimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCacdcc6ce-c190-4de6-b126-62fe9043112e2026-07-07WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC471b1a43-1708-8be7-e063-6394a90a9bb72026-07-06WarningsExact identifier
application number: M012
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC2ee6df99-727a-34c6-e063-6294a90a6bbc2026-07-06WarningsExact 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 SolutionPSN88d0994c-4270-4408-8837-bd97510b211811
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD88d0994c-4270-4408-8837-bd97510b211811
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY88d0994c-4270-4408-8837-bd97510b211811
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSNa9130f36-4761-4e6b-a383-eca3db06ea934
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDa9130f36-4761-4e6b-a383-eca3db06ea934
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYa9130f36-4761-4e6b-a383-eca3db06ea934
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSNefe0117a-0afe-4d79-a01f-7423956130811
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDefe0117a-0afe-4d79-a01f-7423956130811
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYefe0117a-0afe-4d79-a01f-7423956130811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1775-000012117750010 TRAY in 1 CASE (0121-1775-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1775-05) 10 tray2006-10-010000-00-00NoNoCurrent
0121-1775-05001211775055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-1775-100012117751010 TRAY in 1 CASE (0121-1775-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE10 tray2006-10-010000-00-00NoNoCurrent
0121-1775-40001211775404 TRAY in 1 CASE (0121-1775-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1775-05) 4 tray2024-01-10NoNoCurrent