DG Health Cold and Flu Relief

Product NDC
55910-300
11-digit product format
559100300
Labeler code
55910
Product ID
55910-300_81643029-11b4-4a84-b03d-5ad19405517d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Dolgencorp Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-03-27
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325; 15; 6.25 mg/1; mg/1; mg/1
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
2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55910-30055910-300-51DDiscontinued by firm2026-10-21
excluded packagepackage55910-30055910-300-60DDiscontinued by firm2026-10-21

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 · 18 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 2025-12-0555910-300-51d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0555910-300-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2655910-300-51f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2655910-300-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3155910-300-512ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3155910-300-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2855910-300-51a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2855910-300-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2155910-300-51cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2155910-300-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1055910-300-51cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1055910-300-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3155910-300-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2055910-300-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1055910-300-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0855910-300-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0355910-300-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0955910-300-60557ba5c1ecfa…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
DG Health Cold and Flu Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
DOXYLAMINE SUCCINATE6.25 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
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094549Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8cb15a8d-c836-4167-bc6b-dd20a34076e8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-300-51DG Health Cold and Flu Relief2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED27
55910-300-51DG Health Cold and Flu Relief4 in 1 CARTONCAPSULE, LIQUID FILLED47
55910-300-60DG Health Cold and Flu Relief2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED27
55910-300-60DG Health Cold and Flu Relief10 in 1 CARTONCAPSULE, LIQUID FILLED107
55910-300-62DG Health Cold and Flu Relief12 in 1 CARTONCAPSULE, LIQUID FILLED127
55910-300-62DG Health Cold and Flu Relief2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED27

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2DG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
DOXYLAMINEACTIVE MOIETY95QB77JKPLDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
GELATININACTIVE INGREDIENT2G86QN327LDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2
WATERINACTIVE INGREDIENT059QF0KO0RDG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [DOLGENCORP INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-300DG HEALTH COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [DOLGENCORP INC]7Current NDC, Legacy NDC, 6 package rows20241018_8cb15a8d-c836-4167-bc6b-dd20a34076e8.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 29 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLC847cdee8-410f-4ff3-9245-976ed6f4c7762026-05-15WarningsExact identifier
application number: M012
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLCd3b2f300-d919-44cd-ab71-b74b5bdfd9772026-05-15WarningsExact identifier
application number: M012
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVERACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDSMEDWISE LIFESCIENCES INC.51d52ce4-98c4-2b9b-e063-6294a90ade442026-05-15WarningsExact identifier
application number: M012
Curewell Tussin DMDEXTROMETHORPHAN, GUAIFENESINRMT HEALTH LLC4fe9ad93-cdc4-b4df-e063-6294a90a90ae2026-05-15WarningsExact identifier
application number: M012
CounterAct Cough Drops Orchard CherryMENTHOLMelaleuca, Inc.6049842c-d763-4a91-a225-976ed74e16932026-05-15WarningsExact identifier
application number: M012
CounterAct Cough Drops Honey LemonMENTHOLMelaleuca, Inc.84ac3489-9d64-401f-ab78-715af4de54402026-05-15WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.51e03b5b-b05a-07c1-e063-6394a90ab2012026-05-15WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-Drowsy/DaytimeACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLRite Aid Corporation38d73a1e-ac78-4f67-9291-bb48ab80306e2026-05-15WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRWALMART INC.071615ba-f50a-4d2a-a358-43140bccce722026-05-14WarningsExact identifier
application number: M012
Severe Cold and Flu Nighttime DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Incd4bcfabb-a054-4f53-8dc9-d361a03558b82026-05-14WarningsExact identifier
application number: M012
Cough and Chest Congestion DM AdultDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy4444c05a-eba6-4633-b86f-34f455699fa92026-05-14WarningsExact identifier
application number: M012
Topcare Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTopco Associates LLCa88e5b8e-e6dd-4a1c-9628-5861d3205bdb2026-05-14WarningsExact identifier
application number: M012
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc69b24c67-cf4b-46d7-a44b-d1917cc876b12026-05-14WarningsExact identifier
application number: M012
GILTUSS DIABETIC EXGILTUSS DIABETIC EXGil Pharmaceutical Corpab7915e7-323a-4fe1-887a-a3bd3f0aac982026-05-13WarningsExact identifier
application number: M012
Giltuss EX Maximum Strength ExpectorantGILTUSS EX MAXIMUM STRENGTH EXPECTORANTGil Pharmaceutical Corp950db1ca-6936-47f8-a112-e3594d4c922c2026-05-13WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGILTUSS EX EXPECTORANTGil Pharmaceutical Corp3b363fb9-c4d3-446f-927c-f705ffc715b52026-05-13WarningsExact identifier
application number: M012
Giltuss HBP EX ExpectorantGILTUSS HBP EX EXPECTORANTGil Pharmaceutical Corp31bd6356-27cf-4188-8fd5-9cd9392021ca2026-05-13WarningsExact identifier
application number: M012
Halls Honey LemonMENTHOLMondelez Global LLCaec46410-ffb1-4db4-b232-82110c562f692026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Chest Congestion Honey and Berry FlavorGUAIFENESINReckitt Benckiser LLC8ec74cf2-88f5-40be-87e2-b756ab8417542026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and FluACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCc16253d3-3824-458c-8840-e3a2fbe7682c2026-05-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN8cb15a8d-c836-4167-bc6b-dd20a34076e87
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD8cb15a8d-c836-4167-bc6b-dd20a34076e87
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY8cb15a8d-c836-4167-bc6b-dd20a34076e87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-300-51559100300514 BLISTER PACK in 1 CARTON (55910-300-51) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2018-05-210000-00-00NoNoCurrent
55910-300-605591003006010 BLISTER PACK in 1 CARTON (55910-300-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK10 blister pack2014-03-270000-00-00NoNoCurrent
55910-300-625591003006212 BLISTER PACK in 1 CARTON (55910-300-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK12 blister pack2018-05-210000-00-00NoNoCurrent