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 125 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HCLMECLIZINE HCL 25MG CHEWABLE TABLETSAphena Pharma Solutions - Tennessee, LLC02d1af4d-d97d-4019-a5bf-3ec3912386762025-01-09WarningsExact identifier
application number: M012
HISTEX PD Drops New FormulationTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC0c693f15-5d76-3dbf-e063-6294a90af9ac2025-01-08WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HBR 15 MGDEXTROMETHORPHAN HBR 15 MGAMZ789 LLCe2175017-6a0d-0155-e053-2995a90a65d62025-01-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealth Pharma USA LLC29bb7822-76c6-e39d-e063-6294a90a64fb2025-01-07WarningsExact identifier
application number: M012
Childrens Allergy ReliefCHILDRENS ALLERGY RELIEFAllegiant Healthcb6df361-b8e5-4e2f-945f-c20159d76c4f2025-01-06WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLWinCo Foods, LLCbb7a9fed-dc04-4c31-aa7f-4185d955242c2025-01-06WarningsExact identifier
application number: M012
Leader Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leader207b2677-aaad-4fe4-a96d-963b7dcfba702025-01-06WarningsExact identifier
application number: M012
Allergy Relief CapletDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC126c05e7-2cd9-47d3-96c3-82305714e1db2025-01-02WarningsExact identifier
application number: M012
Right Remedies Adult Long Lasting Cough Relief SoftgelDEXTROMETHORPHAN HYDROBROMIDEStrive Pharmaceuticals Inc.e3ea468e-4e12-4dae-b222-8e32456b77b82025-01-02WarningsExact identifier
application number: M012
AVON HeXashield Congestion Relief OriginalOXYMETAZOLINE HYDROCHLORIDETai Guk Pharm. Co., Ltd.8f2c152c-c564-0cba-e053-2a95a90ab3c72025-01-01WarningsExact identifier
application number: M012
Multi-Symptom Nighttime Cold and Flu ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRAdvanced Rx LLCa75553bd-f3f0-47bd-b3c3-aeeb0d1a81b42025-01-01WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEAdvanced Rx LLC297e10e3-e740-4434-91a2-2e5c54985d332025-01-01WarningsExact identifier
application number: M012
MUCUS RELIEF DMGUAIFENESIN, DEXTROMETHORPHAN HBRAdvanced Rx LLC64620186-a45b-4c35-a3b9-a347348f93f72025-01-01WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice57a44bbf-a304-47b9-8adc-4442c77878532025-01-01WarningsExact identifier
application number: M012
Long Acting Cough SoftgelsDEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INC322daee6-c61d-43d3-a54d-a354fd3df2422025-01-01WarningsExact identifier
application number: M012
Adult Tussin DM Lil Drug Store ProductsDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINLil' Drug Store Products, Inc1915cf2a-ebaa-4c47-8991-5b741fa01be22024-12-31WarningsExact identifier
application number: M012
Congestion Relief Lil Drug Store ProductsOXYMETAZOLINE HYDROCHLORIDELil' Drug Store Products, Inc8fca348c-ecb6-4a91-89dd-8bd4c05ac7452024-12-31WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU MULTI SYMPTOMDAYTIME COLD AND FLU MULTI SYMPTOMTARGET CORP9dea350d-2f09-b944-e053-2995a90a2b632024-12-30WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreens2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb2024-12-30WarningsExact identifier
application number: M012
Pediacare Childrens Cough and Cold GrapeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTHfabafdc1-9dd8-4258-af49-bab1e29ad1092024-12-30WarningsExact 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