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 133 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC53b15e75-9efd-4b4b-834b-6e9f12c601082024-12-02WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corpac8a14ac-7023-1e23-e053-2995a90aea3a2024-11-28WarningsExact identifier
application number: M012
Childrens Benadryl DYE-FREE ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC10d478ff-ddc6-45da-87ff-cfe1b2b07a8e2024-11-27WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepack9cd10af6-a2fa-44f8-8df3-a6d2a95a52932024-11-27WarningsExact identifier
application number: M012
Severe Sinus Congestion Allergy and Cough FormulaACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC36a4ec1f-50c3-4d61-ada9-987ccad3563c2024-11-26WarningsExact identifier
application number: M012
Daytime Nighttime Childrens Multi-symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.177e3247-402d-98e4-e063-6294a90ae0682024-11-26WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and Flu, CVPCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLETLil' Drug Store Products, Inc.e7a27773-69d6-9e07-e053-2a95a90af8ea2024-11-25WarningsExact identifier
application number: M012
DayTime Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.4361912e-4b56-4743-b11d-acfb94482a2e2024-11-25WarningsExact identifier
application number: M012
NightTime Sinus ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.413d82d3-a896-4f15-9fca-c1b7b9a1ee632024-11-25WarningsExact identifier
application number: M012
Night Cold Flu Cough and AllergyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.590f4f0d-c8b0-412d-be1e-3eb2ccb29ac02024-11-25WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.cbd3a905-1c41-4cb0-8df6-36784430d6272024-11-25WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.7a28d0fe-0e0a-453a-b604-1cc784dd153c2024-11-25WarningsExact identifier
application number: M012
Cough and Cold plusACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltdc483d88f-cb0a-4dd6-b3ae-559521782ba62024-11-25WarningsExact identifier
application number: M012
DayTime SinusACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.a0b01aef-4248-4d41-862c-0c8884dfca5e2024-11-25WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.3af20739-6794-42e0-b404-3f0401d10a6d2024-11-25WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.ffc7e1e2-b664-461b-963d-764bad2f983f2024-11-25WarningsExact identifier
application number: M012
NightTime SinusACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.0f3b1404-9252-470a-aa8c-b360c85731f32024-11-25WarningsExact identifier
application number: M012
Maximum Strength-Cough and Chest Congestion DMMAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.d1830989-fe82-4f08-8618-78979fcef5682024-11-25WarningsExact identifier
application number: M012
ASP Daytime PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b84f2392-0b24-4af0-80f7-c45454093f512024-11-25WarningsExact identifier
application number: M012
ASP Nighttime MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.d8756d1f-baf5-412d-a493-a1c051eae3022024-11-25WarningsExact 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