FDA.reportPublic FDA data

Dologesic

Product NDC
54859-010
11-digit product format
548590010
Labeler code
54859
Product ID
54859-010_47460679-895e-b4d5-e063-6394a90ab919
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dexbrompheniramine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Llorens Pharmaceutical International Division
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-01
Substance
ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active strength
500; 1 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54859-010-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54859-010-019bebd1f3094a…5416666fcb17…

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
Dologesic
Brand name suffix
DF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DEXBROMPHENIRAMINE MALEATE1 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
BPA9UT29BSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1798453Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
55768b45-fd98-4779-85b6-6a50c628677eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54859-010-012020-12-23C16284748780-19d75b9d0-40d8-f424-e053-dadaa90a57ceLlorens-DologesicDFTab 010
54859-010-012020-01-31C16284748780-19d75b9d0-40d8-f424-e053-dadaa90a57ceLlorens-DologesicDFTab 010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-010-01DologesicDF100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-010-01EA - Each54859-0107702918d-6dcc-4b1e-ad35-95d58fb7267f12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-010DOLOGESIC DF (ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]6Current NDC, Legacy NDC, 1 package rows20241225_55768b45-fd98-4779-85b6-6a50c628677e.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 26 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWALMART INC.321430a5-11c9-4d33-8638-5149f601f1bb2026-05-22WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLDolgencorp Incddcc1e78-4ea8-4489-88e7-86ff460164642026-05-21WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTHACETAMINOPHEN, DEXTROMETHORPHAN HBRAMERISOURCE BERGEN45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e2026-05-21WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC525467fb-510d-0b4b-e063-6294a90acd362026-05-21WarningsExact identifier
application number: M012
Mucinex ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4cee80e5-e412-e832-e063-6394a90aeb902026-05-21WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRReckitt Benckiser LLC4a9464cf-0c77-23d0-e063-6394a90a62f12026-05-21WarningsExact identifier
application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4ceda68e-c7ce-eb87-e063-6394a90a8ded2026-05-21WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.5258ea3f-87f1-7f86-e063-6394a90ab82f2026-05-21WarningsExact identifier
application number: M012
RELIABLE-1 ANTI DRIP PUMP MISTOXYMETAZOLINE HYDROCHLORIDEReliable 1 Laboratories LLC7df9905d-09aa-4c84-8b6f-6e5ed90df0da2026-05-21WarningsExact identifier
application number: M012
daytime nitetimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Inc80abb6b8-b0d5-4f19-8588-50b8717510bb2026-05-21WarningsExact identifier
application number: M012
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEFOXYMETAZOLINE HYDROCHLORIDEFAMILY DOLLAR SERVICES INC27163169-54d0-4b6e-94cd-721b29b182492026-05-20WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Cough FastACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5241b11a-72c8-5e67-e063-6394a90a43532026-05-20WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC50b140ad-aba2-ce6b-e063-6294a90ae2f82026-05-20WarningsExact identifier
application number: M012
Mucinex Fast-Max Recharge Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC4bae240c-70ce-e9c2-e063-6394a90a5f3d2026-05-20WarningsExact identifier
application number: M012
Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC85f7d60b-32ec-4ec2-86ec-f677093bce1d2026-05-20WarningsExact identifier
application number: M012
Chloraseptic Nighttime Sore Throat Hot ReliefACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEPrestige Brands Holdings, Inc.9c13c052-a5d1-43d2-8d29-4ea011a971ac2026-05-20WarningsExact identifier
application number: M012
Cold and Flu Severe, Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporationa0bff310-2d35-4a18-815b-8386e44730a22026-05-19WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.61a1beb3-decf-4c8d-a402-93a02ec40a432026-05-19WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC52291746-2bbf-8f3f-e063-6294a90adcfc2026-05-19WarningsExact identifier
application number: M012
MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift KickstartACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, TRIPROLIDINE HCIReckitt Benckiser LLCfdb70793-5dd1-0455-e053-6394a90ac6212026-05-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletPSN55768b45-fd98-4779-85b6-6a50c628677e7
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletSCD55768b45-fd98-4779-85b6-6a50c628677e7
1798453APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral TabletSY55768b45-fd98-4779-85b6-6a50c628677e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54859-010-0154859001001100 TABLET in 1 BOTTLE (54859-010-01) 100 tablet2016-04-010000-00-00NoNoCurrent