FDA.reportPublic FDA data

COLD RELIEF SEVERE HEAD CONGESTION

Product NDC
41250-275
Requested package NDC
41250-275-02
11-digit product format
412500275
Labeler code
41250
Product ID
41250-275_d070f7d1-5448-4d9c-e053-2a95a90a973d
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Meijer
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-07
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41250-27541250-275-02DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-275-02COLD RELIEF SEVERE HEAD CONGESTION2 in 1 CARTONTABLET, COATED26
41250-275-02COLD RELIEF SEVERE HEAD CONGESTION12 in 1 BLISTER PACKTABLET, COATED126

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
GUAIFENESINACTIVE MOIETY495W7451VQCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9COLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48COLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990COLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-275COLD RELIEF SEVERE HEAD CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]6Legacy NDC, 2 package rows20241013_cb5e6dd3-5985-4559-b7f9-ce06d5f9b114.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLD RELIEF SEVERE HEAD CONGESTIONACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMeijercb5e6dd3-5985-4559-b7f9-ce06d5f9b1142024-10-11WarningsExact identifier
ndc (package): 41250-275-02
ndc (product): 41250-275
ndc11 (package): 41250027502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNcb5e6dd3-5985-4559-b7f9-ce06d5f9b1146
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDcb5e6dd3-5985-4559-b7f9-ce06d5f9b1146
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYcb5e6dd3-5985-4559-b7f9-ce06d5f9b1146
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYcb5e6dd3-5985-4559-b7f9-ce06d5f9b1146

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-275-02412500275022 BLISTER PACK in 1 CARTON (41250-275-02) > 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2014-11-070000-00-00NoNoCurrent