FDA.reportPublic FDA data

Equate Flu and Severe Cold and Cough

Product NDC
49035-964
11-digit product format
490350964
Labeler code
49035
Product ID
49035-964_5bb33798-1c4b-aeaa-e063-6294a90a6758
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-07-11
Marketing end
2027-08-31
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 25; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
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
Equate Flu and Severe Cold and Cough

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

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
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

Related label table
Related label
Wal-Mart Flu & Severe Cold & Cough Drug Facts
Wal-Mart Flu & Severe Cold & Cough Drug Facts
Wal-Mart Flu & Severe Cold & Cough Drug Facts
Wal-Mart Flu & Severe Cold & Cough Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-964-91Equate Flu and Severe Cold and Cough1 in 1 PACKETPOWDER, FOR SOLUTION111
49035-964-91Equate Flu and Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-964-91EA - Each49035-9642f6d0d35-cd4c-443e-8111-3e142f2732bb12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40EQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJEQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MEQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVEQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9EQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1EQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GEQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DEQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULREQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
SUCROSEINACTIVE INGREDIENTC151H8M554EQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28EQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-964EQUATE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAL-MART STORES INC]9Current NDC, Legacy NDC, 2 package rows20240718_90cc8dca-b448-402c-bb48-407039a62616.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 103 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss DGILTUSS DDextrum Laboratories Inc.3f17eefb-b625-b0f2-e063-6294a90afd4d2025-09-18WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMajor Pharmaceuticals6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b2025-09-17WarningsExact identifier
application number: M012
Childrens Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories Inc3effaf4b-28c3-6131-e063-6294a90a17ff2025-09-17WarningsExact identifier
application number: M012
AXIV DayTime - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC1872e1ff-2e08-c404-e063-6294a90afa142025-09-17WarningsExact identifier
application number: M012
AXIV AllergyDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1323a67c-b9c5-038c-e063-6394a90a5e6b2025-09-17WarningsExact identifier
application number: M012
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f025ef6-79e7-e833-e063-6294a90ab5012025-09-17WarningsExact identifier
application number: M012
AXIV Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC186f8519-655d-bd21-e063-6294a90a16a82025-09-17WarningsExact identifier
application number: M012
AXIV NightTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC131f6314-c9a1-7af3-e063-6294a90abe6f2025-09-17WarningsExact identifier
application number: M012
AXIV DayTime - NightTime 48 SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC1320e243-344f-98ed-e063-6294a90a00922025-09-17WarningsExact identifier
application number: M012
AXIV Sinus Severe MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDEVIVUNT PHARMA LLC13245298-8b78-e177-e063-6294a90a6bec2025-09-17WarningsExact identifier
application number: M012
GoodSense Tussin CF Multi-Symptom Cold, RaspberryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.3f05cf84-d485-7688-e063-6394a90ae7402025-09-17WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)5d7466b4-fdb7-432b-880d-e7aa4a4acbda2025-09-17WarningsExact identifier
application number: M012
allergy relief ChildrensDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIe34d8bf5-e12e-453c-93ea-9c7988c4f13d2025-09-16WarningsExact identifier
application number: M012
DayTime Cold Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLC67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f2025-09-16WarningsExact identifier
application number: M012
DOMETUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDomel Laboratories3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe2025-09-16WarningsExact identifier
application number: M012
CareOne Severe Congestion NasalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companyd1dba68b-c4e1-4afc-9aee-6a51341b89f52025-09-16WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)e69ef8dc-09d2-46de-aebf-ba735f4cc7ea2025-09-16WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLL.N.K. International, Inc.f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc52025-09-15WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3ea9a1f2-75b3-c67a-e063-6294a90a8caf2025-09-13WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3eab4cf9-6fdc-a6fb-e063-6394a90a86332025-09-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN90cc8dca-b448-402c-bb48-407039a6261611
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD90cc8dca-b448-402c-bb48-407039a6261611
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY90cc8dca-b448-402c-bb48-407039a6261611
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY90cc8dca-b448-402c-bb48-407039a6261611
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY90cc8dca-b448-402c-bb48-407039a6261611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-964-91490350964916 PACKET in 1 CARTON (49035-964-91) / 1 POWDER, FOR SOLUTION in 1 PACKET6 packet2011-07-112027-08-31NoNoCurrent