FDA.reportPublic FDA data

Acetaminophen,Dextromethorphan,Doxylamine

Product NDC
58805-003
11-digit product format
588050003
Labeler code
58805
Product ID
58805-003_2be66d41-01f7-4c72-9053-3a8206b90143
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen,Dextromethorphan,Doxylamine
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; DOXYLAMINE SUCCINATE
Active strength
325 mg/1; mg/1; mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
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
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product 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
58805-003-042020-01-31C16284748780-19d75b9cf-ed26-f424-e053-dadaa90a57ceAcetaminophen, Dextromethorphan and Doxylamine Night time Cold and Flu
58805-003-142020-01-31C16284748780-19d75b9cf-ed26-f424-e053-dadaa90a57ceAcetaminophen, Dextromethorphan and Doxylamine Night time Cold and Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58805-003-04Acetaminophen,Dextromethorphan,Doxylamine1 in 1 CARTONCAPSULE, LIQUID FILLED14
58805-003-04Acetaminophen,Dextromethorphan,Doxylamine180 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1804
58805-003-14Acetaminophen,Dextromethorphan,Doxylamine1 in 1 CARTONCAPSULE, LIQUID FILLED14
58805-003-14Acetaminophen,Dextromethorphan,Doxylamine7680 in 1 BLISTER PACKCAPSULE, LIQUID FILLED76804

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
DOXYLAMINEACTIVE MOIETY95QB77JKPLACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
GELATININACTIVE INGREDIENT2G86QN327LACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
SORBITOLINACTIVE INGREDIENT506T60A25RACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58805-003ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]4Legacy NDC, 4 package rows20161205_0c3a89d3-9b88-4cc4-bc0e-a95a95824309.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1426334acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral CapsulePSN0c3a89d3-9b88-4cc4-bc0e-a95a958243094
1426334acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD0c3a89d3-9b88-4cc4-bc0e-a95a958243094
1426334APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSY0c3a89d3-9b88-4cc4-bc0e-a95a958243094

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58805-003-04588050003041 in 1 CARTONHistorical
58805-003-14588050003141 in 1 CARTONHistorical