Home NDC 37808-656 DayTime
Product NDC 37808-656
11-digit product format 378080656
Labeler code 37808
Product ID 37808-656_1064a193-f147-4611-9579-858580903f2d
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
Dosage form SOLUTION
Route ORAL
Labeler H E B
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2006-08-02
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 DayTime
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 37808-656-38 DayTime 296 mL in 1 BOTTLE SOLUTION 296 10 37808-656-40 DayTime 355 mL in 1 BOTTLE SOLUTION 355 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 MENTHOL INACTIVE INGREDIENT L7T10EIP3A DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 WATER INACTIVE INGREDIENT 059QF0KO0R DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-656 DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B] 9 Current NDC, Legacy NDC, 2 package rows 20240927_e2994c0f-add8-4f75-a6d2-24cd2af271e4.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 179 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mucus Relief DM MUCUS RELIEF DM TopCo Associates, LLC 71674a9b-89ed-43d1-aadb-b9311fdfbdf9 2022-06-07 Warnings Exact identifier application number: M012 Daytime Nighttime Cold and Flu Relief Combo Pack DAYTIME NIGHTTIME COLD AND FLU Allegiant Health fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 2022-05-19 Warnings Exact identifier application number: M012 Mucus Relief DM Immediate Release MUCUS RELIEF DM Good Sense 26a199bf-57e5-4f36-b40c-83a1187e4870 2022-05-18 Warnings Exact identifier application number: M012 Mucus Relief DM Immediate Release MUCUS RELIEF DM Allegiant Health 731f8608-ad5b-491e-a4d4-2bb0c423fed5 2022-05-18 Warnings Exact identifier application number: M012 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL OPMX LLC b3c229a4-c772-70fb-e053-2a95a90a72db 2022-03-11 Warnings Exact identifier application number: M012 Allergy Relief CHLORPHENIRAMINE MALEATE Good Sense f88e2654-8e97-4cf6-9c36-01aeb51a9102 2021-11-30 Warnings Exact identifier application number: M012 Cold Medicine COLD MEDICINE Allegiant Health 443fbc44-2c33-4316-ad31-dcc5a5aa8f52 2021-11-23 Warnings Exact identifier application number: M012 Decongestant PE Non Drowsy PHENYLEPHRINE HCL Allegiant Health 7a3098b4-381c-4f32-97a7-87b53fd64428 2021-06-16 Warnings Exact identifier application number: M012 Mucus Relief Immediate Release GUAIFENESIN 400MG Good Sense e7c68746-7ec0-46cf-b4a3-174fab819b5e 2021-05-05 Warnings Exact identifier application number: M012 Mucus Relief Immediate Release GUAIFENESIN 400MG TopCo Associates, LLC 7d91c6ab-d161-42b9-b353-0aa8f59619f8 2021-01-21 Warnings Exact identifier application number: M012 Daytime Cold and Flu ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG Allegiant Health bed5f9dc-45ea-4e90-86c6-86599b6f3861 2020-11-16 Warnings Exact identifier application number: M012 Nighttime Cold and Flu Relief ACETAMINOPHEN Allegiant Health b97126d7-847d-483e-b3d1-e2b61ab1743f 2020-11-11 Warnings Exact identifier application number: M012 Cold and Allergy PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE Allegiant Health 7af63769-fa56-4f1f-a2ad-5b4c108c8e4f 2019-12-12 Warnings Exact identifier application number: M012 Mucus Relief Immediate Release GUAIFENESIN Allegiant Health 221d64a2-b8c7-435a-aae4-fb58fd38108f 2019-03-26 Warnings Exact identifier application number: M012 Sleep Tabs For Nighttime use DIPHENHYDRAMINE HCL TABLETS Allegiant Health 566e40b1-e9d7-44e4-b971-eef2b7cf0a7d 2018-12-26 Warnings Exact identifier application number: M012 Allergy CHLORPHENIRAMINE MALEATE Allegiant Health 4305ad50-d2a5-4d3e-9d92-cbf26e856a16 2018-12-26 Warnings Exact identifier application number: M012 Sleep Aid DIPHENHYDRAMINE HCL 25 MG Allegiant Health dbbc535f-515a-4d9b-b799-34e60f5230bb 2018-12-21 Warnings Exact identifier application number: M012 Allergy DIPHENHYDRAMINE HCL Allegiant Health c2823bad-540f-4662-8dcc-58e9f0d94efb 2018-11-07 Warnings Exact identifier application number: M012 Nasal Decongestant PE Maximum Strength Non-Drowsy PHENYLEPHRINE 10 MG Allegiant Health 7aef00df-816a-4ea2-a2ad-beed66dd2fe4 2018-11-07 Warnings Exact identifier application number: M012 DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE Westminster Pharmaceuticals, LLC a58bfb14-28f9-4425-a5a5-aaff4847c979 2018-03-14 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 37808-656-38 37808065638 296 mL in 1 BOTTLE (37808-656-38) 296 ml 2006-08-02 0000-00-00 No No Current 37808-656-40 37808065640 355 mL in 1 BOTTLE (37808-656-40) 355 ml 2012-07-20 0000-00-00 No No Current