FDA.reportPublic FDA data

day time

Product NDC
37808-994
Requested package NDC
37808-994-62
11-digit product format
378080994
Labeler code
37808
Product ID
37808-994_f408560d-e8f4-46bb-844b-622bd56bb3e4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
H E B
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-07-27
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 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
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 · 8 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
day time
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086997Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eaf3af6a-de5b-43fe-83ff-9641646e0f6bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37808-994-602025-11-25HEB Day Time Drug Facts
37808-994-622025-11-25HEB Day Time Drug Facts
37808-994-602025-01-30HEB Day Time Drug Facts
37808-994-622025-01-30HEB Day Time Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-994-60day time2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED27
37808-994-60day time10 in 1 CARTONCAPSULE, LIQUID FILLED107
37808-994-62day time2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED27
37808-994-62day time12 in 1 CARTONCAPSULE, LIQUID FILLED127

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
GELATININACTIVE INGREDIENT2G86QN327LDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3
WATERINACTIVE INGREDIENT059QF0KO0RDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-994DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]6Current NDC, Legacy NDC, 4 package rows20191206_eaf3af6a-de5b-43fe-83ff-9641646e0f6b.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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Childrens Benadryl ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCfc9181b9-c92d-493e-8d7c-4a4239c6c0922026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNeaf3af6a-de5b-43fe-83ff-9641646e0f6b7
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDeaf3af6a-de5b-43fe-83ff-9641646e0f6b7
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYeaf3af6a-de5b-43fe-83ff-9641646e0f6b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-994-623780809946212 BLISTER PACK in 1 CARTON (37808-994-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK12 blister pack2012-07-250000-00-00NoNoCurrent