FDA.reportPublic FDA data

Multi Symptom Severe Cold and Nighttime Severe Cold and Cough

Product NDC
49035-948
11-digit product format
490350948
Labeler code
49035
Product ID
49035-948_44f52e6c-e3b6-1574-e063-6294a90a3be7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl
Dosage form
KIT
Labeler
WAL-MART STORES INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
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
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1189316Internal RxNorm lookup
1659960Internal RxNorm lookup
2640034Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2a7e568-bff8-4818-a31d-7c2efa1859c3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-948-12Multi Symptom Severe Cold and Nighttime Severe Cold and Cough1 in 1 CARTONKIT18
79903-541-01Multi Symptom Severe Cold and Nighttime Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION10 mg8
79903-541-01Multi Symptom Severe Cold and Nighttime Severe Cold and Cough1 in 1 PACKETPOWDER, FOR SOLUTION6500 mg8
79903-547-01Multi Symptom Severe Cold and Nighttime Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION10 mg8
79903-547-01Multi Symptom Severe Cold and Nighttime Severe Cold and Cough1 in 1 PACKETPOWDER, FOR SOLUTION610 mg8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-948MULTI SYMPTOM SEVERE COLD AND NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WAL-MART STORES INC]7Current NDC, Legacy NDC, 5 package rows20241116_a2a7e568-bff8-4818-a31d-7c2efa1859c3.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 134 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLCe07d880b-a12a-4e5e-94c0-bd36bcfe738c2024-12-03WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREbd0a3679-1f7c-4c41-e053-2995a90a8fcb2024-12-03WarningsExact identifier
application number: M012
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCbd09e4f3-3211-8c08-e053-2a95a90a73f92024-12-03WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb373a3a8-68c4-0187-e053-2995a90aad622024-12-03WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All In OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREa1b281ec-fd42-963c-e053-2a95a90a4b712024-12-03WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCb3366ad4-5ef4-eb70-e053-2995a90acf332024-12-03WarningsExact identifier
application number: M012
Meijer Medicated Chest Rub, 3.53 oz. LavenderMENTHOL, CAMPHOR, EUCALYPTUS OILMeijer Distribution22516f25-b8aa-7511-e063-6394a90a61252024-12-03WarningsExact identifier
application number: M012
Tenalif ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cd9513-1a42-e990-e063-6294a90a57df2024-12-03WarningsExact identifier
application number: M012
Tenalif Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cd94e7-1808-3bb3-e063-6294a90a41402024-12-03WarningsExact identifier
application number: M012
Nasal Decongestant PE and Pain Relief Plus Mucus ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC31531f90-8933-46ab-b722-cb63e77386392024-12-03WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWINCO FOODS, LLCf45f3ab4-5e10-3004-e053-2a95a90a0cb42024-12-03WarningsExact identifier
application number: M012
good sense allergyDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.2861b801-e778-822d-e063-6394a90aa1a82024-12-03WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCfe0cf681-f42c-430c-8429-f7ba4bc5a9762024-12-02WarningsExact identifier
application number: M012
Allergy MultisymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5a5aa2ee-51b7-4698-bb27-3fb9d01bbea52024-12-02WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association0ea270b7-9c28-49fb-9615-c4afdbdbc8f12024-12-02WarningsExact identifier
application number: M012
Head Congestion Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC0955d856-cc4e-4ef2-8bc0-1a632a5b5f792024-12-02WarningsExact identifier
application number: M012
Head Congestion Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC40c9c90d-6c9e-40d0-921d-1fd34eff90bb2024-12-02WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC3d068d30-9a00-49d7-bbe9-d6b53c19e86d2024-12-02WarningsExact identifier
application number: M012
DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.76724432-ff3c-404f-ba1f-5af68e3ab8c42024-12-02WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.73d4fc82-8508-44f8-83ca-9f32c5cd847b2024-12-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640034{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) } PackGPCKa2a7e568-bff8-4818-a31d-7c2efa1859c38
26400341 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) PackPSNa2a7e568-bff8-4818-a31d-7c2efa1859c38
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNa2a7e568-bff8-4818-a31d-7c2efa1859c38
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNa2a7e568-bff8-4818-a31d-7c2efa1859c38
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDa2a7e568-bff8-4818-a31d-7c2efa1859c38
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDa2a7e568-bff8-4818-a31d-7c2efa1859c38
26400341 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) PackSYa2a7e568-bff8-4818-a31d-7c2efa1859c38
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYa2a7e568-bff8-4818-a31d-7c2efa1859c38
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYa2a7e568-bff8-4818-a31d-7c2efa1859c38
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYa2a7e568-bff8-4818-a31d-7c2efa1859c38
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYa2a7e568-bff8-4818-a31d-7c2efa1859c38
1189316APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYa2a7e568-bff8-4818-a31d-7c2efa1859c38
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYa2a7e568-bff8-4818-a31d-7c2efa1859c38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-948-12490350948121 KIT in 1 CARTON (49035-948-12) * 6 PACKET in 1 CARTON (79903-541-01) / 1 POWDER, FOR SOLUTION in 1 PACKET * 6 PACKET in 1 CARTON (79903-547-01) / 1 POWDER, FOR SOLUTION in 1 PACKET1 kit2019-07-010000-00-00NoNoCurrent
79903-541-01799030541016 in 1 CARTONHistorical
79903-547-01799030547016 in 1 CARTONHistorical