FDA.reportPublic FDA data

ACETAFLU COUGH AND CHEST CONGESTION

Product NDC
13411-852
Requested package NDC
13411-852-20
11-digit product format
134110852
Labeler code
13411
Product ID
13411-852_2be60640-112d-4b3f-add3-8ffb74ab21a6
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr,Guaifenesin
Dosage form
POWDER
Route
ORAL
Labeler
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-08-31
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/5g; mg/5g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13411-85213411-852-20IInactivated by FDA2026-10-05

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-852-062022-01-28C16284748780-1d6a99b39-afc5-a426-e053-dadaa90af4c2ACETAFLU COUGH & CHEST CONGESTION
13411-852-122022-01-28C16284748780-1d6a99b39-afc5-a426-e053-dadaa90af4c2ACETAFLU COUGH & CHEST CONGESTION
13411-852-202022-01-28C16284748780-1d6a99b39-afc5-a426-e053-dadaa90af4c2ACETAFLU COUGH & CHEST CONGESTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-852-06ACETAFLU COUGH AND CHEST CONGESTION5 g in 1 PACKETPOWDER51
13411-852-06ACETAFLU COUGH AND CHEST CONGESTION6 in 1 BOXPOWDER61
13411-852-12ACETAFLU COUGH AND CHEST CONGESTION5 g in 1 PACKETPOWDER51
13411-852-12ACETAFLU COUGH AND CHEST CONGESTION12 in 1 BOXPOWDER121
13411-852-20ACETAFLU COUGH AND CHEST CONGESTION5 g in 1 PACKETPOWDER51
13411-852-20ACETAFLU COUGH AND CHEST CONGESTION20 in 1 BOXPOWDER201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-852ACETAFLU COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HBR,GUAIFENESIN) POWDER [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 6 package rows20200904_5a6c9b52-255b-48d9-b92e-ded3aa9e29d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2176267dextromethorphan HBr 20 MG / guaiFENesin 400 MG Powder for Oral SolutionPSN5a6c9b52-255b-48d9-b92e-ded3aa9e29d41
2176267dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Powder for Oral SolutionSCD5a6c9b52-255b-48d9-b92e-ded3aa9e29d41
2176267dextromethorphan HBr 20 MG / guaifenesin 400 MG Powder for Oral SolutionSY5a6c9b52-255b-48d9-b92e-ded3aa9e29d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13411-852-201341108522020 PACKET in 1 BOX (13411-852-20) > 5 g in 1 PACKET20 packet2020-08-310000-00-00NoNoCurrent