FDA.reportPublic FDA data

Nighttime Cold and Flu Mini Softgels

Product NDC
83059-0129
11-digit product format
830590129
Labeler code
83059
Product ID
83059-0129_49f47eb2-fc80-7a84-e063-6394a90ae24a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Shield Pharmaceuticals Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-03
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 15; 6.25; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Nighttime Cold and Flu Mini Softgels
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
V9BI9B5YI2Internal 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
2734621Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9af8ab4-a7cb-4adf-9f6f-398c6bb7f853Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83059-0129-1Nighttime Cold and Flu Mini Softgels12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
83059-0129-1Nighttime Cold and Flu Mini Softgels1 in 1 CARTONCAPSULE, LIQUID FILLED12

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 116 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEAurohealth LLC70e1bd25-c32e-491f-b383-91d6f74957a02025-04-28WarningsExact identifier
application number: M012
Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HCLCVS Pharmacy70914691-220c-4fce-9ee1-61a51e8864bc2025-04-26WarningsExact identifier
application number: M012
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions810ce630-41be-4e15-b64a-d70f63abaf622025-04-24WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B5f945975-224f-43eb-b129-a61e3b25c4bb2025-04-22WarningsExact identifier
application number: M012
Walgreens Severe Honey Lemon Throat DropsMENTHOLWalgreens334a9348-2a44-5c94-e063-6394a90ae9562025-04-21WarningsExact identifier
application number: M012
meijer Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bd85bc3-e600-583d-e063-6294a90a7be12025-04-18WarningsExact identifier
application number: M012
Daytime Nighttime Ultra ConcentratedDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKROGER COMPANY2be4a37b-44e1-8a8e-e063-6394a90a26a92025-04-17WarningsExact identifier
application number: M012
good neighbor pharmacy childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEAmerisource Bergencde0fd43-771f-4528-bad2-5727efec52502025-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC729ab412-f30b-4ad1-9d8f-1a5e1c48b1182025-04-16WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.9382c976-3067-4923-a38f-101d1c481e972025-04-11WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HCL LIQUID FILLED CAPSULESWalmart Inc.263d31c8-bdc2-a289-e063-6394a90a4aaa2025-04-10WarningsExact identifier
application number: M012
CVS Wild Cherry Throat DropPECTINCVS31f4b641-e9c0-786e-e063-6394a90aa2532025-04-04WarningsExact identifier
application number: M012
Nighttime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELSWALGREENS2be0a699-e6ad-ef56-e063-6394a90aaca52025-04-03WarningsExact identifier
application number: M012
Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED44fb27d3-5125-4511-84d2-76555bc46e662025-04-03WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION31b8ad0a-3637-03db-e063-6394a90acdc32025-04-01WarningsExact identifier
application number: M012
Pharmacys Prescription Vapor RubMENTHOLAmerican Consumer Products Corp31aa54d8-df8d-f1ae-e063-6294a90a96222025-03-31WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINBryant Ranch Prepack570a71eb-2d19-4c7b-8c00-e1524bfa38442025-03-31WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION365c01b7-a197-4876-85fc-42204f787e3a2025-03-28WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLBryant Ranch Prepack59aeb692-2f79-45aa-8e6a-dab77cd3b2f92025-03-28WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEOncor Pharmaceuticals06ecba97-c790-4672-a8c3-f9caf6272d262025-03-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2734621acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSNb9af8ab4-a7cb-4adf-9f6f-398c6bb7f8532
2734621acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDb9af8ab4-a7cb-4adf-9f6f-398c6bb7f8532
2734621acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsuleSYb9af8ab4-a7cb-4adf-9f6f-398c6bb7f8532
2734621APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYb9af8ab4-a7cb-4adf-9f6f-398c6bb7f8532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83059-0129-1830590129011 BLISTER PACK in 1 CARTON (83059-0129-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2026-02-03NoNoCurrent