FDA.reportPublic FDA data

Cold and Head Congestion

Product NDC
55910-927
11-digit product format
559100927
Labeler code
55910
Product ID
55910-927_a2b6f5d2-da4d-42e0-8bce-5b642e623b19
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOLGENCORP, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-08-06
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
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
Cold and Head Congestion
Brand name suffix
Severe
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1243679Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed28bfa9-3768-4f42-ae5e-1c527b4456d1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-927-08Cold and Head CongestionSevere2 in 1 CARTONTABLET, FILM COATED213
55910-927-08Cold and Head CongestionSevere12 in 1 BLISTER PACKTABLET, FILM COATED1213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-927COLD AND HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]12Current NDC, Legacy NDC, 2 package rows20250321_ed28bfa9-3768-4f42-ae5e-1c527b4456d1.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 66 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier ValueCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2de803-900d-02f4-e063-6394a90a84cc2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS HONEY LEMON SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307f3a7-f6e7-8a5d-e063-6394a90ab7eb2025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2e8fbe-c1c3-79b1-e063-6394a90a4d732025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2dfcc3-e599-3102-e063-6394a90ad54a2025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2ead3c-b4d5-ee8f-e063-6294a90a3c392025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f42644-045b-c4b3-e063-6294a90a48fd2025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS VANILLA HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f45499-bf14-03e4-e063-6394a90a535c2025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f3ddcc-9d4e-f1b1-e063-6294a90ac86f2025-12-29WarningsExact identifier
application number: M012
Menthol Flavor Cough DropMENTHOL FLAVOR COUGH DROPXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a5551-4989-d8fe-e063-6394a90aeabf2025-12-29WarningsExact identifier
application number: M012
MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough DropsMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f2acaa-2cc8-a999-e063-6294a90a15ce2025-12-29WarningsExact identifier
application number: M012
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a92ecc-6a9c-b569-e063-6394a90a8bcb2025-12-29WarningsExact identifier
application number: M012
ValuMeds Allergy Relief Antihistamine Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.a5ceab90-6885-4f3a-b001-97679e03c01b2025-12-29WarningsExact identifier
application number: M012
Goodmeds Non-Drowsy Cough ReliefDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.32482083-3f51-41f4-8d20-bedf143e066d2025-12-29WarningsExact identifier
application number: M012
Tusnel EXGUAIFENESINLlorens Pharmaceutical International Division, Inc.77c16288-68c4-476c-995f-86f5056632702025-12-29WarningsExact identifier
application number: M012
Tusnel DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLlorens Pharmaceutical International Division, Inc.fe457e6d-422d-496c-bcb9-33594f3c42ff2025-12-29WarningsExact identifier
application number: M012
Tusnel DiabeticDEXTROMETHORPHAN, GUAIFENESINLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION66b3c094-809e-4d2c-bc15-46563de685cb2025-12-29WarningsExact identifier
application number: M012
FortifyMENTHOLNatures Formulae Health Products Ltd.781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd2025-12-29WarningsExact identifier
application number: M012
Safetussin PM Nighttime Cough reliefDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKramer Laboratories33dd2245-9abd-4b32-ac76-0f45a54c0f332025-12-29WarningsExact identifier
application number: M012
Winco Foods Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLWinCo Foods, LLCf54eb60d-c602-1272-e053-2995a90aa95a2025-12-28WarningsExact identifier
application number: M012
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCad4d74a8-a762-4378-9016-f7c83421073e2025-12-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNed28bfa9-3768-4f42-ae5e-1c527b4456d113
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDed28bfa9-3768-4f42-ae5e-1c527b4456d113
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYed28bfa9-3768-4f42-ae5e-1c527b4456d113
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYed28bfa9-3768-4f42-ae5e-1c527b4456d113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-927-08559100927082 BLISTER PACK in 1 CARTON (55910-927-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-08-060000-00-00NoNoCurrent