FDA.reportPublic FDA data

Kroger NightTime Cold and Flu SOFTGEL

Product NDC
59450-047
11-digit product format
594500047
Labeler code
59450
Product ID
59450-047_fb4c197e-d90f-43f0-a8db-b997b4748371
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
The Kroger Co.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-08
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325; 15; 6.25 mg/1; mg/1; mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
Kroger NightTime Cold and Flu SOFTGEL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094549Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
24a73de3-e9eb-4cd4-e063-6394a90aa263Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
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0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
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103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
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42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
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c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59450-047-48Kroger NightTime Cold and Flu SOFTGEL12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
59450-047-48Kroger NightTime Cold and Flu SOFTGEL4 in 1 CARTONCAPSULE, LIQUID FILLED42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-047KROGER NIGHTTIME COLD AND FLU SOFTGEL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [THE KROGER CO.]2Current NDC, 2 package rows20250123_24a73de3-e9eb-4cd4-e063-6394a90aa263.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 73 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefDIPHENHYDRAMINE HCLMarc Glassman, Inc.e916ef86-ca73-42dd-83dc-6033f56d96f22025-12-19WarningsExact identifier
application number: M012
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDiscount Drug Marte243033b-6603-4c3e-a330-e7c7de51f69d2025-12-19WarningsExact identifier
application number: M012
CHILDRENS ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart6fa4f913-de83-4175-9dad-0dedab5b69a12025-12-19WarningsExact identifier
application number: M012
Day-Time COLD/FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLDiscount Drug Mart426db906-9aa4-448f-a361-09c1516efc252025-12-19WarningsExact identifier
application number: M012
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDiscount Drug Martf17385bc-82bb-4183-a4c9-067d8afb37572025-12-19WarningsExact identifier
application number: M012
MAXIUM STRENGTH DM MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDiscount Drug Mart9654fdcd-d660-471f-bc5d-aa7dead7a4a82025-12-19WarningsExact identifier
application number: M012
Night Time Multi-Symptom Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDiscount Drug Mart8148c2b1-f6ec-4597-8e18-a6597cda57052025-12-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGNUVICARE LLC621ba20e-75c5-42fb-9692-7800f764c9782025-12-19WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCL 10 MGNUVICARE LLC4cde41dd-a0a7-45e7-aff3-ee9402dfdff22025-12-19WarningsExact identifier
application number: M012
COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2025-12-19WarningsExact identifier
application number: M012
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3df82c-1926-5238-e063-6294a90a7bbf2025-12-18WarningsExact identifier
application number: M012
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fac3425-32f0-38d6-e063-6394a90a6e7a2025-12-18WarningsExact identifier
application number: M012
NAFASOLINANAPHAZOLINE HYDROCHLORIDEDoral Pharmamedics Inc DBA AG Marin Pharmaceuticals30cade3d-208f-8594-e063-6394a90ad2a02025-12-18WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropHONEY LEMON FLAVOR COUGH DROPArmy & Air Force Exchange Service20ac8a20-206c-0024-e063-6394a90a9d062025-12-18WarningsExact identifier
application number: M012
Menthol Flavor Cough DropMENTHOL FLAVOR COUGH DROPArmy & Air Force Exchange Service20ace10f-4257-b20e-e063-6394a90a3c7b2025-12-18WarningsExact identifier
application number: M012
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fabd782-14dc-1d1b-e063-6394a90af4282025-12-18WarningsExact identifier
application number: M012
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3c6b38-7236-899b-e063-6294a90aabde2025-12-18WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREEMENTHOLChain Drug Marketing Association, Inc.8f6ee01c-baad-489f-b2fd-0ef506916ee42025-12-18WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLMeijer5baeaff7-172c-187a-e053-2a91aa0ab1652025-12-18WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLMeijer Distribution Inc.3bee752a-4141-1f5b-e054-00144ff8d46c2025-12-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCKa11d3a31-2c72-40c2-bd78-dd93903b8daf2
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSNa11d3a31-2c72-40c2-bd78-dd93903b8daf2
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNa11d3a31-2c72-40c2-bd78-dd93903b8daf2
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN24a73de3-e9eb-4cd4-e063-6394a90aa2632
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNa11d3a31-2c72-40c2-bd78-dd93903b8daf2
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDa11d3a31-2c72-40c2-bd78-dd93903b8daf2
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD24a73de3-e9eb-4cd4-e063-6394a90aa2632
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDa11d3a31-2c72-40c2-bd78-dd93903b8daf2
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSYa11d3a31-2c72-40c2-bd78-dd93903b8daf2
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYa11d3a31-2c72-40c2-bd78-dd93903b8daf2
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY24a73de3-e9eb-4cd4-e063-6394a90aa2632
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYa11d3a31-2c72-40c2-bd78-dd93903b8daf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59450-047-48594500047484 BLISTER PACK in 1 CARTON (59450-047-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2025-01-08NoNoCurrent