FDA.reportPublic FDA data

tabcin ACTIVE

Product NDC
69729-152
11-digit product format
697290152
Labeler code
69729
Product ID
69729-152_5d345460-8406-ef2f-e063-6294a90a3f03
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
2023-11-28
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
2027-12-31
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
tabcin ACTIVE
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
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
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79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
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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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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
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e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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
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
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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
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-152-10tabcin ACTIVE1 in 1 CARTONCAPSULE, LIQUID FILLED13
69729-152-10tabcin ACTIVE10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-152TABCIN ACTIVE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [OPMX LLC.]2Current NDC, 2 package rows20240407_0b3eb8c3-9b9e-861b-e063-6294a90a4a0f.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 73 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefDIPHENHYDRAMINE HCLMarc Glassman, Inc.e916ef86-ca73-42dd-83dc-6033f56d96f22025-12-19WarningsExact identifier
application number: M012
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDiscount Drug Marte243033b-6603-4c3e-a330-e7c7de51f69d2025-12-19WarningsExact identifier
application number: M012
CHILDRENS ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart6fa4f913-de83-4175-9dad-0dedab5b69a12025-12-19WarningsExact identifier
application number: M012
Day-Time COLD/FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLDiscount Drug Mart426db906-9aa4-448f-a361-09c1516efc252025-12-19WarningsExact identifier
application number: M012
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDiscount Drug Martf17385bc-82bb-4183-a4c9-067d8afb37572025-12-19WarningsExact identifier
application number: M012
MAXIUM STRENGTH DM MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDiscount Drug Mart9654fdcd-d660-471f-bc5d-aa7dead7a4a82025-12-19WarningsExact identifier
application number: M012
Night Time Multi-Symptom Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDiscount Drug Mart8148c2b1-f6ec-4597-8e18-a6597cda57052025-12-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGNUVICARE LLC621ba20e-75c5-42fb-9692-7800f764c9782025-12-19WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCL 10 MGNUVICARE LLC4cde41dd-a0a7-45e7-aff3-ee9402dfdff22025-12-19WarningsExact identifier
application number: M012
COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2025-12-19WarningsExact identifier
application number: M012
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3df82c-1926-5238-e063-6294a90a7bbf2025-12-18WarningsExact identifier
application number: M012
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fac3425-32f0-38d6-e063-6394a90a6e7a2025-12-18WarningsExact identifier
application number: M012
NAFASOLINANAPHAZOLINE HYDROCHLORIDEDoral Pharmamedics Inc DBA AG Marin Pharmaceuticals30cade3d-208f-8594-e063-6394a90ad2a02025-12-18WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropHONEY LEMON FLAVOR COUGH DROPArmy & Air Force Exchange Service20ac8a20-206c-0024-e063-6394a90a9d062025-12-18WarningsExact identifier
application number: M012
Menthol Flavor Cough DropMENTHOL FLAVOR COUGH DROPArmy & Air Force Exchange Service20ace10f-4257-b20e-e063-6394a90a3c7b2025-12-18WarningsExact identifier
application number: M012
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fabd782-14dc-1d1b-e063-6394a90af4282025-12-18WarningsExact identifier
application number: M012
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3c6b38-7236-899b-e063-6294a90aabde2025-12-18WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREEMENTHOLChain Drug Marketing Association, Inc.8f6ee01c-baad-489f-b2fd-0ef506916ee42025-12-18WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLMeijer5baeaff7-172c-187a-e053-2a91aa0ab1652025-12-18WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLMeijer Distribution Inc.3bee752a-4141-1f5b-e054-00144ff8d46c2025-12-18WarningsExact 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 CapsulePSN0b3eb8c3-9b9e-861b-e063-6294a90a4a0f3
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD0b3eb8c3-9b9e-861b-e063-6294a90a4a0f3
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY0b3eb8c3-9b9e-861b-e063-6294a90a4a0f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69729-152-10697290152101 BLISTER PACK in 1 CARTON (69729-152-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2023-11-28NoNoCurrent