Home NDC 60432-608-16 PROMETHAZINE HYDROCHLORIDE
Product NDC 60432-608
Requested package NDC 60432-608-16
11-digit product format 604320608
Labeler code 60432
Product ID 60432-608_365a7dfe-15d5-4b78-8d4d-5341ffeb7872
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name promethazine hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Morton Grove Pharmaceuticals, Inc.
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 2020-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A087953-001 PROMETHAZINE PLAIN PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087953-001 AA
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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Promethazine Hydrochloride ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 Promethazine ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 SODIUM PROPIONATE INACTIVE INGREDIENT DK6Y9P42IN PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 WATER INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS] 3 Promethazine Hydrochloride ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 Promethazine Hydrochloride ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 Promethazine ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 Promethazine ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM PROPIONATE INACTIVE INGREDIENT DK6Y9P42IN PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM PROPIONATE INACTIVE INGREDIENT DK6Y9P42IN PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 2 Promethazine Hydrochloride ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 Promethazine Hydrochloride ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 Promethazine ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 Promethazine ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 ascorbic acid INACTIVE INGREDIENT PQ6CK8PD0R PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 edetate disodium INACTIVE INGREDIENT 7FLD91C86K PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 SODIUM PROPIONATE INACTIVE INGREDIENT DK6Y9P42IN PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 sodium propionate INACTIVE INGREDIENT DK6Y9P42IN PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 water INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60432-608 PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 5 Legacy NDC 20191106_3919fb0c-a0b6-470b-9ff2-63600bcbfbc9.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 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60432-608-16 60432060816 473 mL in 1 BOTTLE, PLASTIC (60432-608-16) 473 ml 1982-11-15 0000-00-00 No No Current