FDA.reportPublic FDA data

NDC 70518-2628-02 - ACETAMINOPHEN AND CODEINE PHOSPHATE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70518-2628
Requested NDC
70518-2628-02
Package NDCs from labels
70518-2628-0, 70518-2628-1, 70518-2628-2, 70518-2628-02
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACETAMINOPHEN AND CODEINE PHOSPHATE - REMEDYREPACK INC.REMEDYREPACK INC.2026-07-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-131fe39679-fd58-4d2c-ba61-49d492a2b087
2023-03-131fe39679-fd58-4d2c-ba61-49d492a2b087
2023-03-131fe39679-fd58-4d2c-ba61-49d492a2b087
2023-01-301fe39679-fd58-4d2c-ba61-49d492a2b087
2023-01-301fe39679-fd58-4d2c-ba61-49d492a2b087
2023-01-301fe39679-fd58-4d2c-ba61-49d492a2b087

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2628-0ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BLISTER PACKTABLET3012
70518-2628-1ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BLISTER PACKTABLET3012
70518-2628-2ACETAMINOPHEN AND CODEINE PHOSPHATE60 in 1 BOTTLE, PLASTICTABLET6012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2628ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 3 package rows20250326_1fe39679-fd58-4d2c-ba61-49d492a2b087.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2628-0EA - Each70518-2628fd480f84-b10e-4833-9835-bee92f4e75ae12023-01-09

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 198 · 3,958 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-07-30WarningsExact identifier
unii: 362O9ITL9D
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
unii: 362O9ITL9D
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
unii: 362O9ITL9D
HeadacheMELILOTUS OFFICINALIS, SPIGELIA ANTHELMIA, ALLIUM CEPA, BELLADONNA, BRYONIA (ALBA), CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, SANGUINARIA CANADENSIS, SILICEA, TARENTULA CUBENSISBioActive Nutritionals, Inc.918bc478-78a2-41e1-b123-f5350cf8f43a2026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.4c966d73-77c6-4514-954e-57aa06a080c62026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211610
rxcui: 993890
unii: GSL05Y1MN6
unii: 362O9ITL9D
KinderFarms Infants Pain and FeverACETAMINOPHENKinderFarms, LLC5468b149-8fac-8d6a-e063-6294a90a8c512026-07-29WarningsExact identifier
unii: 362O9ITL9D
PERCOCETOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENEndo USA, Inc.4dd36cf5-8f73-404a-8b1d-3bd53bd90c252026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
oxycodone and acetaminophenOXYCODONE AND ACETAMINOPHENFH2 Pharma LLC88d97caf-bcf5-3cde-e053-2995a90acf4a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ProlateOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENForte Bio-Pharma LLC9d75ad3b-bc9b-0c22-e053-2a95a90ac71e2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSpecGx LLCf2137f1a-b49a-40bd-97ac-cd6b36e295f42026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.1fe39679-fd58-4d2c-ba61-49d492a2b0872026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211610
ndc (package): 70518-2628-2
ndc (package): 70518-2628-1
ndc (package): 70518-2628-0
ndc (product): 70518-2628
ndc11 (package): 70518262802
rxcui: 993781
spl id: 579d40e5-fea2-fd54-e063-6394a90afab1
spl set id: 1fe39679-fd58-4d2c-ba61-49d492a2b087
unii: GSL05Y1MN6
unii: 362O9ITL9D
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporation17d27771-a112-474f-9a58-29af0d7e1af32026-07-27WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
unii: 362O9ITL9D
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
unii: 362O9ITL9D