FDA.reportPublic FDA data

Non-Drowsy Sinus Severe, Circle K

Product NDC
66715-5632
11-digit product format
667155632
Labeler code
66715
Product ID
66715-5632_0c7f0538-050c-81f2-e063-6394a90adf57
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, Phenylephrine HCl caplet, film-coated
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lil' Drug Store products, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-01
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
200; 5; 325 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
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
Non-Drowsy Sinus Severe, Circle K
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
495W7451VQInternal UNII lookup
362O9ITL9DInternal 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
e78c456f-f62e-596d-e053-2995a90a2397Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-5632-3Non-Drowsy Sinus Severe, Circle K2 in 1 BLISTER PACKTABLET, FILM COATED22
66715-5632-3Non-Drowsy Sinus Severe, Circle K3 in 1 CARTONTABLET, FILM COATED32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-5632NON-DROWSY SINUS SEVERE, CIRCLE K (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2Current NDC, Legacy NDC, 2 package rows20231215_e78c456f-f62e-596d-e053-2995a90a2397.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 52 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLHy-Vee, Inc.446de381-6685-748d-e063-6394a90a1b732026-02-04Warnings, Adverse reactionsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED85aadc86-d979-41a1-849a-e2ccc90144292026-02-04WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Incfa8c154c-56c6-47de-8e43-9e012b4be95f2026-02-04WarningsExact identifier
application number: M012
Foster and Thrive Cherry Cough DropsMENTHOLMcKesson49eefa70-cef9-d7ec-e063-6294a90ac3212026-02-03WarningsExact identifier
application number: M012
Foster and Thrive Honey Lemon Cough DropsMENTHOLMcKesson49f13ee3-6bb3-e500-e063-6394a90a152d2026-02-03WarningsExact identifier
application number: M012
Daytime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp63cb19d4-2306-4723-a95e-9d2d8b9eccd02026-02-03WarningsExact identifier
application number: M012
Foster and Thrive SF Honey Lemon Cough DropsMENTHOLMcKesson49f41c30-f806-44ba-e063-6394a90a5a672026-02-03WarningsExact identifier
application number: M012
Nighttime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corpb9af8ab4-a7cb-4adf-9f6f-398c6bb7f8532026-02-03WarningsExact identifier
application number: M012
allergy reliefDIPHENHYDRAMINE HCLMeijer Distribution Inc7c2fc244-bfc5-4e3c-aa90-8bc3d067b64f2026-02-03WarningsExact identifier
application number: M012
Cold and Allergy DPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLWalgreen Company832ac849-7f4a-489a-a704-9d4388a75a712026-02-03WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc987f908b-7af7-4705-bfb4-c48d771c380d2026-02-03WarningsExact identifier
application number: M012
tussin dm nighttime maxDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Inc1f3fb451-84c9-432e-ac67-2694dd66c8152026-02-03WarningsExact identifier
application number: M012
Robafen DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINMajor Pharmaceuticals7c9660b7-cb00-449b-b65f-aa42d8ce19422026-02-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company6b0d261f-fc27-4b34-88b1-cd3d727667602026-02-02WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINCardinal Health 110, LLC. DBA Leaderebfcb699-3369-4697-9841-44015b1c98082026-02-02WarningsExact identifier
application number: M012
Cherry Sore Throat LozengesBENZOCAINE, MENTHOLMeijer Distribution Inc.2f6de590-7cad-25d7-e054-00144ff8d46c2026-02-02WarningsExact identifier
application number: M012
Mixed Berry Sore Throat and Cough lozengeDEXTROMETHORPHAN HYDROBROMIDEMeijer Distribution, Inc.304ff4db-201a-60a4-e054-00144ff8d46c2026-02-02WarningsExact identifier
application number: M012
Allergy Relief Plus CongestionDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company38d91107-d95c-40f2-a27e-561f951e519d2026-02-02WarningsExact identifier
application number: M012
Tussin SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHyVee Inc85252999-3463-45fe-b4a9-7a97960b41b12026-02-02WarningsExact identifier
application number: M012
Amazon Basics Cherry Cough Drops 30ctMENTHOLAmazon3e74e209-c9c9-3979-e063-6294a90afcfa2026-02-01WarningsExact 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 TabletPSNe78c456f-f62e-596d-e053-2995a90a23972
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe78c456f-f62e-596d-e053-2995a90a23972
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYe78c456f-f62e-596d-e053-2995a90a23972
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYe78c456f-f62e-596d-e053-2995a90a23972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-5632-3667155632033 BLISTER PACK in 1 CARTON (66715-5632-3) / 2 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2022-08-010000-00-00NoNoCurrent