FDA.reportPublic FDA data

Green Guard Advanced Sinus Relief

Product NDC
47682-001
11-digit product format
476820001
Labeler code
47682
Product ID
47682-001_3e4c0f0f-30cb-6e2b-e063-6294a90accbc
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-12-30
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
500; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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
Green Guard Advanced Sinus Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal 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
1101534Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8e5fb21-a7fd-44d1-b9c4-83e949699ca6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-001-33Green Guard Advanced Sinus Relief50 in 1 BOXTABLET5015
47682-001-33Green Guard Advanced Sinus Relief2 in 1 PACKETTABLET215
47682-001-48Green Guard Advanced Sinus Relief125 in 1 BOXTABLET12515
47682-001-99Green Guard Advanced Sinus Relief2 in 1 PACKETTABLET215

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DGREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJGREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DGREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVGREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EGREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-001GREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]14Current NDC, Legacy NDC, 4 package rows20241116_e8e5fb21-a7fd-44d1-b9c4-83e949699ca6.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 51 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEBryant Ranch Prepack09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b2026-02-17WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Ince8a48a00-3533-4c4d-94e1-8a6c6b35a7922026-02-17WarningsExact identifier
application number: M012
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Inc1f3efcdd-4976-4aef-a7c6-a5f88d13cb782026-02-17WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Incd5bbb5e1-ff09-4563-b2c6-149ab30e06ad2026-02-17WarningsExact identifier
application number: M012
Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRChain Drug Marketing Association, Inc.3c8f34ad-589a-4872-939c-44ad5e0e47fe2026-02-17WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLValu Merchandisers Companyb6144732-99da-4be2-88e0-75f31b323d382026-02-16Warnings, Adverse reactionsExact identifier
application number: M012
topcare day time cold and flu relief multi symptom reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates LLC6d08ca2d-6ae4-443f-9920-34b7fb46f2b42026-02-16WarningsExact identifier
application number: M012
Revasol Acetaminophen SuspensionACETAMINOPHENRnv LLC4ab6bb54-7c28-0c6b-e063-6394a90ac4a62026-02-13WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTopco Associates LLC62eed0e8-ba5f-45c2-a543-68b50bcf4b0c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M012
Revasol Acetaminophen Suspension Dye FreeACETAMINOPHENRnv LLC4abc07b3-6a27-260f-e063-6394a90a28d62026-02-13WarningsExact identifier
application number: M012
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMajor Pharmaceuticals5e19220d-9cf3-4732-b9aa-c09db5d69ce62026-02-13WarningsExact identifier
application number: M012
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC686b9456-f16d-4b99-ae58-f607448bed8b2026-02-13WarningsExact identifier
application number: M012
nasalPHENYLEPHRINE HYDROCHLORIDEKroger Company1c3dc4e6-452b-4c84-b53c-426cf9ae8f032026-02-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFIaf42d3f7-661e-4322-aefe-2b7f9f1010d62026-02-12WarningsExact identifier
application number: M012
Childrens Giltuss DCHILDRENS GILTUSS DGil Pharmaceutical Corpcfc2493b-e99e-4b55-98a9-053f95d498442026-02-12WarningsExact identifier
application number: M012
Giltuss DGILTUSS DGil Pharmaceutical Corp298f5457-a7df-474d-9854-68918ee3d3302026-02-12WarningsExact identifier
application number: M012
VaporizingCAMPHORWalgreen Co.ef4f95c8-7650-4096-9369-ea8393781bee2026-02-12Warnings, Adverse reactionsExact identifier
application number: M012
Oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDEProdose, Inc.3dce34f0-9f6d-8151-e063-6394a90a1d382026-02-11WarningsExact identifier
application number: M012
SIGNATURE CARE Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESAFEWAY831da7b6-25c7-4601-b7f1-1800a238b0162026-02-11WarningsExact identifier
application number: M012
Allergy Plus Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d2cf481-622f-4262-b0bd-c38fe5de67212026-02-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101534acetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSNe8e5fb21-a7fd-44d1-b9c4-83e949699ca615
1101534acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe8e5fb21-a7fd-44d1-b9c4-83e949699ca615
1101534APAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYe8e5fb21-a7fd-44d1-b9c4-83e949699ca615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-001-334768200013350 PACKET in 1 BOX (47682-001-33) / 2 TABLET in 1 PACKET50 packet2008-12-300000-00-00NoNoCurrent
47682-001-4847682000148125 PACKET in 1 BOX (47682-001-48) / 2 TABLET in 1 PACKET (47682-001-99) 125 packet2008-12-300000-00-00NoNoCurrent
47682-001-99476820001992 TABLET in 1 PACKET (47682-001-99) 2 tablet2008-12-300000-00-00NoNoCurrent