Home NDC 56062-656 day time
Product NDC 56062-656
11-digit product format 560620656
Labeler code 56062
Product ID 56062-656_b57c0992-a1bd-4577-9d7f-7364f864124d
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan HBr, Phenylephrine HCl
Dosage form SOLUTION
Route ORAL
Labeler Publix Super Markets Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2006-06-08
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
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
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.
Additional Listing Data#
Finished product Yes
Brand name base day time
Brand name suffix non drowsy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/15mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1113705 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 56062-656-38 day timenon drowsy 296 mL in 1 BOTTLE SOLUTION 296 9 56062-656-40 day timenon drowsy 355 mL in 1 BOTTLE SOLUTION 355 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 MENTHOL INACTIVE INGREDIENT L7T10EIP3A DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 56062-656 DAY TIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC] 8 Current NDC, Legacy NDC, 2 package rows 20240927_f4fd597f-bca2-4ed4-b353-6c734f2f885c.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 100 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Freegells Cough Drops Menthol 80ct MENTHOL RL Albert & Son Inc. c96cc162-5908-4990-9dc1-3ce912844274 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL R.L. ALBERT & SON, INC bac77712-6197-4b30-a5f8-9b99eb9d7b5a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL R.L. ALBERT & SON, INC 6842d766-ade6-40b2-831b-f4feac25c6db 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL RL Albert & Son Inc. 9f324ca1-0e2a-47e3-997e-2aaa68a85751 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 30ct MENTHOL R.L. ALBERT & SON, INC 2063a013-aa0b-465d-b04f-cfe2e70d749f 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 200ct MENTHOL R.L. ALBERT & SON, INC cd81488c-74d8-48d9-9c73-ff662a5cd4cd 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 80ct MENTHOL R.L. ALBERT & SON, INC 61deea94-d0a9-4563-926b-53f255a7c425 2025-10-08 Warnings Exact identifier application number: M012 FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS MENTHOL R.L. ALBERT & SON, INC c6b36350-386b-4346-bef0-a37ec11319c0 2025-10-08 Warnings Exact identifier application number: M012 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 3314b174-d5bb-4843-9288-9b9c5fce79d5 2025-10-08 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL CVS Pharmacy 22f55699-4922-4c05-bdf5-5844c7dd3ee5 2025-10-07 Warnings Exact identifier application number: M012 OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution DIPHENHYDRAMINE HCL MEDWISE LIFESCIENCES INC. 407b7cbb-7ebd-7b7e-e063-6394a90af501 2025-10-06 Warnings Exact identifier application number: M012 Quality Choice Medicated Chest Rub CAMPHOR, MENTHOL, EUCALYPTUS OIL Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc 2025-10-06 Warnings Exact identifier application number: M012 Halls Sugar Free Honey Lemon MENTHOL Mondelez Global LLC 2b19fdd2-8088-47f2-be20-f220a6b825fc 2025-10-06 Warnings Exact identifier application number: M012 Giltuss Childrens Cough and Chest Congestion DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Dextrum Laboratories, Inc 40802fb6-c1ec-d7b0-e063-6394a90ab423 2025-10-06 Warnings Exact identifier application number: M012 Giltuss Diabetic DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Dextrum Laboratories, Inc 3f64c81a-bbfc-4575-e063-6294a90a6ed7 2025-10-06 Warnings Exact identifier application number: M012 TexaClear Severe Cough, Cold and Flu CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN GM Pharmaceuticals, INC cb99e5b3-1908-43c9-b31f-d35e7ce58b44 2025-10-06 Warnings Exact identifier application number: M012 RoboHBr Cough SUPPRESSANT DEXTROMETHORPHAN HBR DXM Pharmaceutical, Inc 0af624ce-191f-45e1-882b-e8acb90cc77b 2025-10-06 Warnings Exact identifier application number: M012 RoboTablets DEXTROMETHORPHAN DXM Pharmaceutical, Inc b92cf698-032d-4d8d-b19c-456c6338b094 2025-10-06 Warnings Exact identifier application number: M012 SinuLief LORATADINE RoseWell Pharmaceuticals LLC 32619143-a782-3497-e063-6394a90aaaec 2025-10-06 Warnings Exact identifier application number: M012 STAHIST AD CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE Magna Pharmaceuticals, Inc. ccedbc38-2479-4c35-9f86-a9f29bcfab3f 2025-10-03 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 56062-656-38 56062065638 296 mL in 1 BOTTLE 296 ml Historical 56062-656-40 56062065640 355 mL in 1 BOTTLE (56062-656-40) 355 ml 2014-03-27 0000-00-00 No No Current