FDA.reportPublic FDA data

Acetaminophen,Dextromethorphan,Phenylephrine

Product NDC
58805-002
11-digit product format
588050002
Labeler code
58805
Product ID
58805-002_641e15a2-c46c-4171-8918-4f752d79231d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen,Dextromethorphan,Phenylephrine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Agile Pharmachem
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-05-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
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7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
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
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ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
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22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
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105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
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c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
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d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58805-002-082020-01-31C16284748780-19d75b9d0-dd32-f424-e053-dadaa90a57ceAcetaminophen, Dextromethorphan and Phenylephrine Day time Cold and Flu
58805-002-142020-01-31C16284748780-19d75b9d0-dd32-f424-e053-dadaa90a57ceAcetaminophen, Dextromethorphan and Phenylephrine Day time Cold and Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58805-002-08Acetaminophen,Dextromethorphan,Phenylephrine8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED83
58805-002-08Acetaminophen,Dextromethorphan,Phenylephrine180 in 1 CARTONCAPSULE, LIQUID FILLED1803
58805-002-14Acetaminophen,Dextromethorphan,Phenylephrine7680 in 1 BLISTER PACKCAPSULE, LIQUID FILLED76803
58805-002-14Acetaminophen,Dextromethorphan,Phenylephrine1 in 1 CARTONCAPSULE, LIQUID FILLED13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
GELATININACTIVE INGREDIENT2G86QN327LACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621ACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
SORBITOLINACTIVE INGREDIENT506T60A25RACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58805-002ACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]3Legacy NDC, 4 package rows20150116_563452d1-0c19-4094-895a-805c859bc49b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN563452d1-0c19-4094-895a-805c859bc49b3
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD563452d1-0c19-4094-895a-805c859bc49b3
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY563452d1-0c19-4094-895a-805c859bc49b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58805-002-08588050002088 in 1 BLISTER PACKHistorical
58805-002-14588050002147680 in 1 BLISTER PACKHistorical