FDA.reportPublic FDA data

Desresfriol-DX Softgels

Product NDC
69729-121
11-digit product format
697290121
Labeler code
69729
Product ID
69729-121_155f7122-feb9-c81f-e063-6294a90ab72d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
OPMX LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 325; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [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
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
Desresfriol-DX Softgels
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
362O9ITL9DInternal 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
1086997Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff5e0e0f-bfd2-b02b-e053-6394a90afe8aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-121-10Desresfriol-DX Softgels1 in 1 CARTONCAPSULE, LIQUID FILLED12
69729-121-10Desresfriol-DX Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-121DESRESFRIOL-DX SOFTGELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [OPMX LLC.]2Current NDC, 2 package rows20240407_ff5e0e0f-bfd2-b02b-e053-6394a90afe8a.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 49 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company97554f40-f9aa-4dbf-a6f2-de6197236ab42026-02-25WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFamily Dollar Stores, Inc1b50b865-3dfc-4b3f-86d5-5e91ca7724452026-02-24Warnings, Adverse reactionsExact identifier
application number: M012
VaproizingCAMPHORH E B577fda09-588a-4c2e-ada5-eeda32d1aabe2026-02-24Warnings, Adverse reactionsExact identifier
application number: M012
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLMajor Pharmaceuticals11416620-4892-44ba-9780-db27efff67432026-02-24WarningsExact identifier
application number: M012
Family Wellness SF Honey Lemon Cough DropsMENTHOLFamily Dollar4437853d-1f42-a41d-e063-6294a90aa81e2026-02-24WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)64a93715-e7b1-4de1-8099-8ad6c585d5172026-02-24WarningsExact identifier
application number: M012
Cough and Chest Congestion DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED86af74c2-9183-4ee9-ad1e-d88dfc8bf47d2026-02-24WarningsExact identifier
application number: M012
Cough DM NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED39adf23e-76f3-42e1-a9f4-55feb38078e52026-02-24WarningsExact identifier
application number: M012
Revasol Tussin DM Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINRnv LLC4b7fd320-2f39-fa1a-e063-6294a90ada9e2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and AllergyBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brands47317865-4310-4f07-8815-f3130963307d2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDEFoundation Consumer Brands42720fa0-fcdd-4614-80b2-16d0ada345b12026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brandscc09a8c5-d173-4261-b838-96e6a16e2ff92026-02-23WarningsExact identifier
application number: M012
Dimetapp Nighttime Cold and CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brands96a1055f-e831-4f4b-8af3-7a41838c194c2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Nighttime Cold and CongestionDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Brands1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2462026-02-23WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLBetter Living Brands, LLC0948648c-1c5f-4225-a754-120ca8859f192026-02-23Warnings, Adverse reactionsExact identifier
application number: M012
Revasol TussinGUAIFENESINRnv LLCf66dc593-9023-40e8-9cc3-0380b04b43052026-02-23WarningsExact identifier
application number: M012
Equate VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc3006971b-784c-43fd-91a6-d96876bbf1852026-02-23WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals04e70311-6412-4a20-84e3-f6e26d5f19ab2026-02-20WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals7f2b72cc-d4f7-431f-be61-c103cf8c489e2026-02-20WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticalsdca04d80-e781-40b1-e053-2995a90a70102026-02-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNff5e0e0f-bfd2-b02b-e053-6394a90afe8a2
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDff5e0e0f-bfd2-b02b-e053-6394a90afe8a2
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYff5e0e0f-bfd2-b02b-e053-6394a90afe8a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69729-121-10697290121101 BLISTER PACK in 1 CARTON (69729-121-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2023-06-30NoNoCurrent