FDA.reportPublic FDA data

nighttime

Product NDC
59779-459
11-digit product format
597790459
Labeler code
59779
Product ID
59779-459_8de57c97-88c8-4808-94ff-27cb7dfd9f0c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-12
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-45959779-459-30DDiscontinued by firm2026-10-16
excluded packagepackage59779-45959779-459-34DDiscontinued by firm2026-10-16
excluded packagepackage59779-45959779-459-38DDiscontinued by firm2026-10-16
excluded packagepackage59779-45959779-459-50DDiscontinued by firm2026-10-16

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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0559779-459-38d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-459-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-459-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-459-34d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2659779-459-38f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-459-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-459-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-459-34f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3159779-459-382ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159779-459-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159779-459-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2859779-459-38a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859779-459-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859779-459-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2159779-459-38cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159779-459-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159779-459-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1059779-459-38cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059779-459-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059779-459-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3159779-459-38302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159779-459-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159779-459-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2059779-459-38ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059779-459-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059779-459-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1059779-459-380efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059779-459-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059779-459-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0859779-459-38ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0859779-459-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0859779-459-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0359779-459-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0359779-459-38367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0959779-459-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0959779-459-38557ba5c1ecfa…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
nighttime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

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
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043400Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1c341cf5-ac33-4a6e-b023-a23d280d496cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-459-30nighttime177 mL in 1 BOTTLESOLUTION17710
59779-459-34nighttime237 mL in 1 BOTTLESOLUTION23710
59779-459-38nighttime295 mL in 1 BOTTLESOLUTION29510
59779-459-40nighttime355 mL in 1 BOTTLESOLUTION35510
59779-459-50nighttime355 mL in 1 BOTTLESOLUTION35510
59779-459-50nighttime2 in 1 PACKAGESOLUTION210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-459-34ML - Milliliter59779-459da64554e-5461-46f0-9f45-f214e929596412018-11-06
59779-459-40ML - Milliliter59779-45986a3ea00-c6ce-48da-9553-b79c91e016bd12023-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
DOXYLAMINEACTIVE MOIETY95QB77JKPLNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5
WATERINACTIVE INGREDIENT059QF0KO0RNIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-459NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]10Current NDC, Legacy NDC, 6 package rows20241027_1c341cf5-ac33-4a6e-b023-a23d280d496c.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 80 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cherry throat relief lozengesBENZOCAINECintas Corporation49b25e9e-1d47-4a10-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
cherry sore throat lozengeBENZOCAINECVS Pharmacy3c54974d-9d15-2fa1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
honey lemon sore throat lozengesBENZOCAINECVS Pharmacy3c55009c-4b3e-135e-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLCVS Pharmacy3bdd24a8-3b44-00cd-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLCVS Pharmacy3c125b3a-e58f-5c06-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
CVS Menthol Cough DropsMENTHOLCVS Pharmacyde97d13b-bb67-d0e6-e053-2995a90aeb2c2025-12-07WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLAmerican Sales34dd34d1-1a08-3470-e054-00144ff8d46c2025-12-06WarningsExact identifier
application number: M012
DOLOGENACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEKramer Novis656ea9ba-c9cf-44c6-af40-b8ba292ce38a2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLCa79b5541-864b-412a-a085-96986ed6af592025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.346f32cb-74cb-4896-b770-76d5f829a17d2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.530b2d27-5883-489e-87fa-90b45eb93b3c2025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Cough and Cold Cough Suppressant, AntihistamineCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.ee666963-e686-4374-b52b-a677f1cd41142025-12-05WarningsExact identifier
application number: M012
Afrin No-Drip Allergy SinusOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC3beb5839-7422-449d-e054-00144ff88e882025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Nighttime Multi-Symptom ColdACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.513ca24f-1262-4a2d-e054-00144ff8d46c2025-12-05WarningsExact identifier
application number: M012
Afrin Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.a49a506e-aca2-4af0-a50b-dca2c031e61d2025-12-05WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.a746cef4-1fb4-45cf-e053-2995a90a02c82025-12-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINHealth Pharma USA LLC31755594-3e1c-b290-e063-6394a90aba612025-12-05WarningsExact identifier
application number: M012
Tabcin Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL,Pharmadel LLC0670c33e-8a3c-ae00-e063-6294a90a165b2025-12-05WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corpd0dd4a75-da65-4c66-b65f-54ee141008462025-12-05WarningsExact identifier
application number: M012
Basic Care Cherry Cough DropsMENTHOLAmazon.comc0588221-0c84-66d8-e053-2995a90a874f2025-12-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN1c341cf5-ac33-4a6e-b023-a23d280d496c10
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD1c341cf5-ac33-4a6e-b023-a23d280d496c10
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY1c341cf5-ac33-4a6e-b023-a23d280d496c10
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY1c341cf5-ac33-4a6e-b023-a23d280d496c10
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY1c341cf5-ac33-4a6e-b023-a23d280d496c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-459-3059779045930177 mL in 1 BOTTLE (59779-459-30) 177 ml2011-09-160000-00-00NoNoCurrent
59779-459-3459779045934237 mL in 1 BOTTLE (59779-459-34) 237 ml2012-07-050000-00-00NoNoCurrent
59779-459-3859779045938295 mL in 1 BOTTLE (59779-459-38) 295 ml2011-08-120000-00-00NoNoCurrent
59779-459-4059779045940355 mL in 1 BOTTLE (59779-459-40) 355 ml2011-08-190000-00-00NoNoCurrent
59779-459-50597790459502 BOTTLE in 1 PACKAGE (59779-459-50) > 355 mL in 1 BOTTLE (59779-459-40) 2 bottle2011-08-190000-00-00NoNoCurrent