FDA.reportPublic FDA data

Sunmark Chest Congestion Relief PE

Product NDC
49348-774
11-digit product format
493480774
Labeler code
49348
Product ID
49348-774_06fe6676-29a9-4deb-aa91-b28365e68afb
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin/phenylephrine
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-06-05
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
400; 10 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
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
Sunmark Chest Congestion Relief PE
Brand name suffix
PE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
1304111Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f94ae469-4c79-4ce9-9a3d-3bdc645be6d9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-774-09Sunmark Chest Congestion Relief PEPE1 in 1 CARTONTABLET14
49348-774-09Sunmark Chest Congestion Relief PEPE50 in 1 BOTTLETABLET504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-774-09EA - Each49348-774eac4436c-69b7-407d-9dff-5cfe4755e47612014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQSUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1
GuaifenesinACTIVE MOIETY495W7451VQSUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-774SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20241220_f94ae469-4c79-4ce9-9a3d-3bdc645be6d9.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 157 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.445e49a2-6ed0-434c-aaea-3ce14bc7df592024-08-12WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.d49b42ad-0ae0-48c9-adba-5fc2ced977642024-08-12WarningsExact identifier
application number: M012
RYMEDDEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDEEDWARDS PHARMACEUTICALS, INC.c1d6e914-74cc-4cdf-9587-7eaaa4a386e52024-08-12WarningsExact identifier
application number: M012
WesTussin DM NFWESTUSSIN DM NFWestminster Pharmaceuticals, LLC4e0f9f97-a31c-41ac-9d6c-d81efd20fcef2024-08-08WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.2f2a2864-af11-4240-bdad-a54aca58d01b2024-08-07WarningsExact identifier
application number: M012
Cold plus Flu Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.0199aea2-a9c1-4c9d-8786-28b9dadc832e2024-08-07WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.32d1ce6e-2617-4b50-a9e6-2e1941465dff2024-08-07WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.07362db5-a372-4463-af8b-06e8783ca8652024-08-07WarningsExact identifier
application number: M012
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.1fb11d90-48bf-4baa-9b3a-5d64d81e3a062024-08-07WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.574774b2-9813-4799-9cd4-27e296dd85842024-08-07WarningsExact identifier
application number: M012
Cold Max Day and NIghtACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.a92bcefb-ba29-4b3f-a60b-b4476ca8cf042024-08-07WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.778f1f5a-fd04-456f-90d0-998b93e774a52024-08-07WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.990f3232-bc75-45cf-8a50-cd7861d83f982024-08-07WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.0f5f25c6-7389-4285-b8d5-463cb7b6fcc42024-08-07WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATECare One (Retail Business Services, LLC.)a9a5b39d-b4c8-414e-8fe7-4c0601f751972024-08-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEAmerican Health Packagingb94feeb6-f33f-410d-a9b0-776b1ccf34a92024-08-04WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEAmerican Health Packaging4cd8aee3-5522-434b-a1b1-9591bed3e9a62024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging8632a655-7f5b-450f-95fa-62478a174e9c2024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging990906b3-c566-4f35-923c-060202ba48e02024-08-04WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropsHONEY LEMON FLAVOR MENTHOLWHOLE FOODS MARKET, INC.1eb7abdc-061f-0e18-e063-6294a90a3a652024-08-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304111guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral TabletPSNf94ae469-4c79-4ce9-9a3d-3bdc645be6d94
1304111guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDf94ae469-4c79-4ce9-9a3d-3bdc645be6d94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-774-09493480774091 BOTTLE in 1 CARTON (49348-774-09) / 50 TABLET in 1 BOTTLE1 bottle2019-08-290000-00-00NoNoCurrent