FDA.reportPublic FDA data

Pain and Sinus

Product NDC
73598-1192
11-digit product format
735981192
Labeler code
73598
Product ID
73598-1192_a7785144-b14d-455e-aed4-85536e0a54f6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Phenylephrine
Dosage form
TABLET
Route
ORAL
Labeler
JHK Inc dba American Safety & First Aid
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-09
Substance
ACETAMINOPHEN; PHENYLEPHRINE
Active strength
500; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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
Pain and Sinus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
PHENYLEPHRINE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
1WS297W6MVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1101534Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
88f86f5a-cc2b-4c75-b7a4-f2021922280bAvailable 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
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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
73598-1192-1Pain and Sinus2 in 1 PACKETTABLET22
73598-1192-1Pain and Sinus50 in 1 BOXTABLET502

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 115 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin DM Sugar freeDEXTROMETHORPHAN HBR AND GUAIFENESINAARNA USA, Inc.3a521b65-fb35-4cc3-b826-88513afda0f92025-05-16WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC51c7628a-c7cf-498f-8fb1-db732e2b8b6e2025-05-16WarningsExact identifier
application number: M012
BACTIMICINA CHILDRENS ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEDLC Laboratories, Inc.eaf554d4-a758-4ed6-bec5-d6cbfedae4082025-05-15WarningsExact identifier
application number: M012
Bactimicina Childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEDLC Laboratories, Inc.d407a583-07ae-4d47-b15a-24b5865c82da2025-05-15WarningsExact identifier
application number: M012
Mucinex Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDERB Health (US) LLC35322238-d498-1a52-e063-6394a90ac9c42025-05-15WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLCa1405038-80f2-45e5-bd8c-8c6b0ee348be2025-05-15WarningsExact identifier
application number: M012
Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIb919f0fe-fae0-4bd8-9ccd-d7569b2a70702025-05-13WarningsExact identifier
application number: M012
Childrens Robitussin Honey Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC6afaf85b-bf0c-4c99-acf3-a34f06be20f12025-05-13WarningsExact identifier
application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC77be57fb-0ae5-4fad-97f3-b6a4b57383a92025-05-13WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEBryant Ranch Prepackc948e612-a491-4ad0-adb9-cf31ef76e4d82025-05-12WarningsExact identifier
application number: M012
Maximum Strength Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.c3d0b70f-d213-4e38-88ab-1c89d93a391d2025-05-10WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDESafeway, Inc.c639a36d-c683-4a4d-90b7-eadec7464aa22025-05-08WarningsExact identifier
application number: M012
Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcf2dd1fb-1d5b-428e-8c9a-a46dbd7cb6452025-05-07WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC2b962d87-6ff5-4c0f-8504-e5b61c9406122025-05-05WarningsExact identifier
application number: M012
Cough and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUIDCVS2d13564a-e8d1-c357-e063-6394a90ad90e2025-05-02WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling MentholOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33fe0e49-3de5-8afd-e063-6294a90a0ad52025-05-02WarningsExact identifier
application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy, Inc.2d13964a-8cc4-f3dc-e063-6394a90aa1052025-05-02WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HCL 12.5 MG PER 5 MLDIPHENHYDRAMINE HCL 12.5 MG PER 5 MLAARNA USA INC.32c26835-f54e-d7e5-e063-6294a90ae1c02025-04-30WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33e6239b-364a-0e62-e063-6294a90a50472025-04-29WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCVS Pharmacy8296049c-72fc-4200-9d45-c8e377314cf22025-04-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101534acetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN88f86f5a-cc2b-4c75-b7a4-f2021922280b2
1101534acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD88f86f5a-cc2b-4c75-b7a4-f2021922280b2
1101534APAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY88f86f5a-cc2b-4c75-b7a4-f2021922280b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73598-1192-17359811920150 PACKET in 1 BOX (73598-1192-1) / 2 TABLET in 1 PACKET50 packet2024-05-09NoNoCurrent