Childrens Dimetapp Multi-Symptom Cold and Flu

Product NDC
0031-2249
Requested package NDC
0031-2249-04
11-digit product format
000312249
Labeler code
0031
Product ID
0031-2249_1e5f973d-b229-40b3-afd3-f7559be20b70
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-01-01
Marketing end
2022-09-30
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
320 mg/10mL; mg/10mL; mg/10mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0031-22490031-2249-04DDiscontinued by firm2026-10-12

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0031-2249-042020-04-15C16284748780-19d75b9d0-47b6-f424-e053-dadaa90a57ceDrug Facts
0031-2249-042020-01-31C16284748780-19d75b9d0-47b6-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-2249-04ML - Milliliter0031-224986e753db-4786-43f5-a922-c8cc15ec279d12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ACHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-2249-04000312249041 BOTTLE in 1 CARTON (0031-2249-04) > 118 mL in 1 BOTTLE1 bottle2020-01-012022-09-30NoNoCurrent