FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
17856-0608
Requested package NDC
17856-0608-5
11-digit product format
178560608
Labeler code
17856
Product ID
17856-0608_3cebf14a-409b-495b-8a5f-4f3f0d7ec1c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA087953
Marketing category
ANDA
Marketing start
1982-11-15
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
6 mg/5mL
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17856-060817856-0608-5IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087953-001PROMETHAZINE PLAINPROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAARLD, RS1982-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A087953-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A087953-001PROMETHAZINE PLAIN6.25MG/5MLSYRUP / ORALAARLD, RS1982-11-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A087953-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEAtlantic Biologicals Corp.4f99bbd5-02f7-2fed-e063-6394a90a63552026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087953
application number: ANDA087953
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXttrium Laboratories, Inc.302bfea2-d403-d315-e063-6294a90a37dd2025-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087953
application number: ANDA087953

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0608-52024-05-15C16284748780-19d75b9d1-1b00-f424-e053-dadaa90a57cePROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP)
17856-0608-52023-01-30C16284748780-19d75b9d1-1b00-f424-e053-dadaa90a57cePROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP)
17856-0608-52021-09-02C16284748780-19d75b9d1-1b00-f424-e053-dadaa90a57cePROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP)
17856-0608-52020-01-31C16284748780-19d75b9d1-1b00-f424-e053-dadaa90a57cePROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0608-5Promethazine Hydrochloride5 mL in 1 CUPSYRUP55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0608-5ML - Milliliter17856-06085d4da32d-e749-4d01-91f6-cd9f1cf4ad4e12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0608PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.]5Legacy NDC, 1 package rows20240517_bbdbc61c-3923-4832-b0a5-c0365dd8f5f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNbbdbc61c-3923-4832-b0a5-c0365dd8f5f95
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDbbdbc61c-3923-4832-b0a5-c0365dd8f5f95
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSYbbdbc61c-3923-4832-b0a5-c0365dd8f5f95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0608-5178560608055 mL in 1 CUP (17856-0608-5) 5 ml2021-09-020000-00-00NoNoCurrent