FDA.reportPublic FDA data

foster and thrive daytime cold and flu relief nighttime cold and flu relief

Product NDC
70677-1028
11-digit product format
706771028
Labeler code
70677
Product ID
70677-1028_57e7c322-7212-4e0d-a81b-98ad5c71870d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
Dosage form
KIT
Labeler
Strategic Sourcing Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-30
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
foster and thrive daytime cold and flu relief nighttime cold and flu relief
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086997Internal RxNorm lookup
1094549Internal RxNorm lookup
2634564Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1ecc56b-8052-4b0a-900a-dc93a24771bdAvailable 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
0113-1000-00foster and thrive daytime cold and flu relief nighttime cold and flu relief8 in 1 CARTONCAPSULE, LIQUID FILLED15 mg2
0113-1000-00foster and thrive daytime cold and flu relief nighttime cold and flu relief2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1615 mg2
0113-2101-00foster and thrive daytime cold and flu relief nighttime cold and flu relief16 in 1 CARTONCAPSULE, LIQUID FILLED10 mg2
0113-2101-00foster and thrive daytime cold and flu relief nighttime cold and flu relief2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED325 mg2
70677-1028-1foster and thrive daytime cold and flu relief nighttime cold and flu relief1 in 1 CARTONKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1028-1EA - Each70677-1028ebea119b-4454-4a59-a8e0-78839b0f2b5012024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1028FOSTER AND THRIVE DAYTIME COLD AND FLU RELIEF NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 5 package rows20241116_c1ecc56b-8052-4b0a-900a-dc93a24771bd.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 3 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dollar GeneralNASAL PHENYLEPHRINE HYDROCHLORIDEDOLGENCORP, INC. (DOLLAR GENERAL & REXALL)e8fd3f0e-a023-4423-8906-17ae02bc083b2026-09-03WarningsExact identifier
application number: M012
Mucus Relief Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCITARGET Corporation1bf9a59e-cc37-4780-ba75-7138c546eb192026-09-02WarningsExact identifier
application number: M012
Childrens Multi Symptom Fever and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTHE KROGER CO.3daf7620-eb57-43d5-ba88-938b7221e3462026-09-02WarningsExact identifier
application number: M012
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corp69fd13a1-2b76-8574-e053-2a91aa0a27e72026-09-02WarningsExact identifier
application number: M012
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corp.a6880389-0dc1-43a7-a73b-77f77bafe51e2026-09-02WarningsExact identifier
application number: M012
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corpfa8510d8-d50a-4743-ba87-a12e9ab431252026-09-02WarningsExact identifier
application number: M012
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corpdfcf1231-8271-458d-b375-e328d6fd4e9b2026-09-02WarningsExact identifier
application number: M012
Nighttime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEShield Pharmaceuticals Corpdecafa3a-3734-4161-bab0-1219458818462026-09-02WarningsExact identifier
application number: M012
Kroger Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLKROGER COMPANY1ff037ea-1a3b-430a-be31-2e240cc3b6f32026-09-02WarningsExact identifier
application number: M012
KROGER Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINKROGER COMPANY79d24014-1af7-4d62-bcb8-5bea76a7d6ee2026-09-02WarningsExact identifier
application number: M012
Kroger No DripALLERGY SINUSKROGER COMPANY4788bafb-8866-4a0a-b217-226513799c242026-09-02WarningsExact identifier
application number: M012
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
application number: M012
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
application number: M012
KROGER Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2bea22e9-34b6-4961-94bb-5600dd90e8912026-09-02WarningsExact identifier
application number: M012
KROGER No Drip Nasal Mist Severe CongestionOXYMETAZOLINE HYDROCHLORIDEKROGER COMPANY7256e048-ad69-4322-844d-872f05e6fc8a2026-09-02WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
application number: M012
MAX Tussin Cough and Chest Congestion DM Sugar FreeDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.5c4c8115-cec9-4f2c-9ea9-328535e97b072026-09-01WarningsExact identifier
application number: M012
MAX ALLERGY KIDSDIPHENHYDRAMINE HCLAkron Pharma Inc.96c4ade8-67b1-41e5-8624-fb49090208af2026-09-01WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREEHEXYLRESORCINOL AND MENTHOLReckitt Benckiser LLC4a938e15-a996-8538-e063-6294a90ad4ee2026-09-01WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEWALMART INC.5e6623c3-6210-4c50-94d6-5554f36876d12026-08-31WarningsExact 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) } PackGPCKc1ecc56b-8052-4b0a-900a-dc93a24771bd2
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) PackPSNc1ecc56b-8052-4b0a-900a-dc93a24771bd2
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNc1ecc56b-8052-4b0a-900a-dc93a24771bd2
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNc1ecc56b-8052-4b0a-900a-dc93a24771bd2
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDc1ecc56b-8052-4b0a-900a-dc93a24771bd2
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDc1ecc56b-8052-4b0a-900a-dc93a24771bd2
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) PackSYc1ecc56b-8052-4b0a-900a-dc93a24771bd2
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYc1ecc56b-8052-4b0a-900a-dc93a24771bd2
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYc1ecc56b-8052-4b0a-900a-dc93a24771bd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-1000-00001131000008 in 1 CARTONHistorical
0113-2101-000011321010016 in 1 CARTONHistorical
70677-1028-1706771028011 KIT in 1 CARTON (70677-1028-1) * 8 BLISTER PACK in 1 CARTON (0113-1000-00) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON (0113-2101-00) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 kit2023-10-30NoNoCurrent