FDA.reportPublic FDA data

Ampigrin Ultra Forte Night

Product NDC
69729-003
11-digit product format
697290003
Labeler code
69729
Product ID
69729-003_3a229cae-7c0d-a174-e063-6394a90a2efc
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
OPMX LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-10
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN
Active strength
15; 6.25; 325 mg/1; mg/1; mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct69729-003IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69729-00369729-003-10IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
Ampigrin Ultra Forte Night
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1
ACETAMINOPHEN325 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
V9BI9B5YI2Internal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094549Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e11e71c3-fe7c-77c7-e053-2995a90a34b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-003-102024-04-05C16284748780-11030e365-4177-111a-e063-dadaa90a10e2Ampigrin Ultra Forte - Night
69729-003-102024-01-30C16284748780-11030e365-4177-111a-e063-dadaa90a10e2Ampigrin Ultra Forte - Night

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-003-10Ampigrin Ultra Forte Night10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103
69729-003-10Ampigrin Ultra Forte Night10 in 1 CARTONCAPSULE, LIQUID FILLED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-003AMPIGRIN ULTRA FORTE NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [OPMX LLC]2Current NDC, Legacy NDC, 2 package rows20240407_e11e71c3-fe7c-77c7-e053-2995a90a34b2.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 69 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Menthol Chewable GelsMENTHOLWalmart1ba4b2be-7242-0a23-e063-6294a90af29c2025-12-23WarningsExact identifier
application number: M012
Walgreens Severe Menthol Throat DropsMENTHOLWalgreens21dd3c68-cbc6-4799-e063-6394a90a69722025-12-23WarningsExact identifier
application number: M012
cherry throat relief lozengesBENZOCAINEZee Medical499d0748-538f-678c-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINNuCare Pharmaceuticals, Inc.46a480c7-7092-b809-e063-6294a90a60cd2025-12-23WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLWinco Foods360a6304-206d-5475-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLWinco Foods36342d8c-34ab-6178-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLWinco Foods37244333-1307-5121-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLWinco foods37718c73-880e-4a5c-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLWinco Foods40676ddc-577f-5cc9-e054-00144ff88e882025-12-23WarningsExact identifier
application number: M012
Sugar Free Menthol Cough DropsMENTHOLWinco Foods3788e8b6-ab9e-1513-e054-00144ff88e882025-12-23WarningsExact identifier
application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestionDEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIESeeca6370-29ea-4540-8139-e8461d58a2862025-12-23WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDiscount Drug Martdd31f86b-f59e-459a-8e5f-176828706a4a2025-12-23WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDiscount Drug Martf8e7a08e-7422-4a1b-bfec-93e0b50d10cd2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ae97-7951-4058-e053-2995a90a7b2e2025-12-23WarningsExact identifier
application number: M012
Childrens Chest Congestion Relief GrapeGUAIFENESINDiscount Drug Mart3e5d245f-515c-4106-a855-fb97681b646a2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ed16-86bb-3faf-e053-2995a90acfbc2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCa7999da7-148a-4c6d-a2ea-0f4cc1d5b2832025-12-23WarningsExact identifier
application number: M012
Safetussin High Blood Pressure and diabetes Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES279e309c-040d-4001-808d-b7d986a9a1d82025-12-23WarningsExact identifier
application number: M012
Sinus PE Head Congestion and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED76fd1f8e-2670-421c-a9e6-c8adefb7962e2025-12-23WarningsExact identifier
application number: M012
Leader Cough Drops Vanilla HoneyMENTHOLCardinal Health 110, LLC. DBA Leader1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e22025-12-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNe11e71c3-fe7c-77c7-e053-2995a90a34b23
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDe11e71c3-fe7c-77c7-e053-2995a90a34b23
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYe11e71c3-fe7c-77c7-e053-2995a90a34b23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69729-003-106972900031010 BLISTER PACK in 1 CARTON (69729-003-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK10 blister pack2022-06-100000-00-00NoNoCurrent