Home NDC 21130-560-08 Pain Relief
Product NDC 21130-560
Requested package NDC 21130-560-08
11-digit product format 211300560
Labeler code 21130
Product ID 21130-560_91276d0c-9b37-4f8b-9c01-2264ae75f72d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler Better Living Brands, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2008-03-29
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 21130-560-08 21130056008 2 BLISTER PACK in 1 CARTON (21130-560-08) > 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2008-03-29 0000-00-00 No No Current